Fastener, Fixation, Biodegradable, Soft Tissue (MAI) contract manufacturers
38 US facilities list FDA product code MAI as a contract manufacturer (21) or contract sterilizer (20).
FDA-registered (openFDA, export of Oct 21, 2026)
- FDA device name
- Fastener, Fixation, Biodegradable, Soft Tissue
- Product code
- MAI (FDA product classification database)
- Device class
- Class II
- Regulation
- 21 CFR 888.3030
- Classification panel
- Orthopedic
- FDA flags
- implant
Where they are
Indiana 4 · California 3 · Florida 3 · Massachusetts 3 · New York 3 · Connecticut 2 · Georgia 2 · Minnesota 2 · North Carolina 2 · New Jersey 2 · South Carolina 2 · Utah 2 and 7 more states
All 38 facilities
| Company | FDA registration | Establishment type | Device categories | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| Aptyx - Charlotte | 3011324393 | Contract manufacturer | Orthopedic; Cardiovascular; Gastroenterology and urology +3 more | Charlotte, NC | Not verified | Oct 21, 2026 |
| Arthrex Manufacturing Inc. | 3015231789 | Contract manufacturer and sterilizer | Orthopedic; General and plastic surgery; General hospital +7 more | Pendleton, SC | Not verified | Oct 21, 2026 |
| Arthrex, Inc. | 3010331645 | Contract manufacturer and sterilizer | Orthopedic; General and plastic surgery; General hospital +9 more | Ave Maria, FL | Not verified | Oct 21, 2026 |
| ATC TECHNOLOGIES INC. | 1225798 | Contract manufacturer | Gastroenterology and urology; Ophthalmic; Obstetrics and gynecology +4 more | Wilmington, MA | Not verified | Oct 21, 2026 |
| BLUE LINE STERILIZATION SERVICES | 3009905888 | Contract sterilizer | General and plastic surgery; Cardiovascular; Ophthalmic +4 more | Novato, CA | Not verified | Oct 21, 2026 |
| C&A Tool Engineering, Inc. Auburn Plant | 3014252644 | Contract manufacturer | Orthopedic; General and plastic surgery; Neurology | Auburn, IN | Not verified | Oct 21, 2026 |
| C+A TOOL ENGINEERING, INC. | 1836357 | Contract manufacturer | Orthopedic; General and plastic surgery; Neurology +1 more | Churubusco, IN | Not verified | Oct 21, 2026 |
| CLASSIC WIRE CUT COMPANY, INC. | 2031917 | Contract manufacturer | Orthopedic; General and plastic surgery; Neurology +2 more | Valencia, CA | Not verified | Oct 21, 2026 |
| CONMED CORPORATION | 1320894 | Contract manufacturer | Orthopedic; Cardiovascular; Obstetrics and gynecology +1 more | Utica, NY | Not verified | Oct 21, 2026 |
| DSM Biomedical, Inc. | 2530154 | Contract manufacturer | Orthopedic; General and plastic surgery; Dental +2 more | Exton, PA | Not verified | Oct 21, 2026 |
| INTERNATIONAL STERILIZATION LABORATORY, LLC | 1061927 | Contract sterilizer | Orthopedic; General and plastic surgery; Gastroenterology and urology +9 more | Groveland, FL | Not verified | Oct 21, 2026 |
| ISOMEDIX OPERATIONS INC. | 1047843 | Contract sterilizer | General and plastic surgery; Gastroenterology and urology; Orthopedic +13 more | Spartanburg, SC | Not verified | Oct 21, 2026 |
| ISOMEDIX OPERATIONS INC. | 1220477 | Contract sterilizer | Orthopedic; General and plastic surgery; General hospital +14 more | Northborough, MA | Not verified | Oct 21, 2026 |
| ISOMEDIX OPERATIONS INC. | 1319660 | Contract sterilizer | Orthopedic; General and plastic surgery; Ophthalmic +10 more | Chester, NY | Not verified | Oct 21, 2026 |
| ISOMEDIX OPERATIONS INC. | 2245304 | Contract sterilizer | Orthopedic; General and plastic surgery; Dental +9 more | Whippany, NJ | Not verified | Oct 21, 2026 |
| Isomedix Operations Inc. | 2246552 | Contract sterilizer | General and plastic surgery; Orthopedic; Gastroenterology and urology +12 more | S Plainfield, NJ | Not verified | Oct 21, 2026 |
| Isomedix Operations, Inc. | 1450662 | Contract sterilizer | Orthopedic; General and plastic surgery; Cardiovascular +11 more | Libertyville, IL | Not verified | Oct 21, 2026 |
| Life Science Outsourcing | 1221051 | Contract manufacturer and sterilizer | Orthopedic; General and plastic surgery; Dental +6 more | Somersworth, NH | Not verified | Oct 21, 2026 |
| LIFENET HEALTH | 3005064037 | Contract manufacturer | Orthopedic; General and plastic surgery | Virginia Beach, VA | Not verified | Oct 21, 2026 |
| LifeNet Health | 3005381997 | Contract manufacturer | Orthopedic; General and plastic surgery | Virginia Bch, VA | Not verified | Oct 21, 2026 |
| LifeNet Health | 3015724777 | Contract manufacturer | Orthopedic; General and plastic surgery | Plainfield, IN | Not verified | Oct 21, 2026 |
| LINEMASTER SWITCH CORP. | 3001592626 | Contract manufacturer | General and plastic surgery; Cardiovascular; Neurology +5 more | Woodstock, CT | Not verified | Oct 21, 2026 |
| Paragon Medical Inc. | 1000517406 | Contract manufacturer | Orthopedic; General and plastic surgery; Neurology | Smithfield, UT | Not verified | Oct 21, 2026 |
| PARAGON MEDICAL, INC. | 1834331 | Contract manufacturer | Orthopedic; General and plastic surgery; Neurology +4 more | Pierceton, IN | Not verified | Oct 21, 2026 |
| R.K. Manufacturing | 1226146 | Contract manufacturer | Orthopedic; General and plastic surgery; Gastroenterology and urology +3 more | Danbury, CT | Not verified | Oct 21, 2026 |
| RMS CO. | 2183946 | Contract manufacturer | Orthopedic; Neurology; General and plastic surgery +4 more | Minneapolis, MN | Not verified | Oct 21, 2026 |
| Spectrum Plastics Group | 2183967 | Contract manufacturer | Orthopedic; General and plastic surgery; Cardiovascular +3 more | Saint Louis Park, MN | Not verified | Oct 21, 2026 |
| Sterigenics Radiation Technologies, LLC | 2024024 | Contract sterilizer | Cardiovascular; General and plastic surgery; Dental +8 more | San Diego, CA | Not verified | Oct 21, 2026 |
| Sterigenics U.S. LLC | 1054811 | Contract sterilizer | Orthopedic; General and plastic surgery; Ophthalmic +13 more | Mulberry, FL | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 1018470 | Contract sterilizer | General and plastic surgery; Orthopedic; General hospital +12 more | Atlanta, GA | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 1319639 | Contract sterilizer | Cardiovascular; General and plastic surgery; Gastroenterology and urology +14 more | Queensbury, NY | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 1721676 | Contract sterilizer | Cardiovascular; Orthopedic; General and plastic surgery +12 more | Salt Lake City, UT | Not verified | Oct 21, 2026 |
| Sterigenics US LLC | 1058584 | Contract sterilizer | General and plastic surgery; Orthopedic; General hospital +14 more | Charlotte, NC | Not verified | Oct 21, 2026 |
| Sterigenics US LLC | 3002907620 | Contract sterilizer | Orthopedic; General and plastic surgery; General hospital +12 more | West Memphis, AR | Not verified | Oct 21, 2026 |
| Sterigenics US, LLC | 1526534 | Contract sterilizer | Orthopedic; General and plastic surgery; General hospital +14 more | Lewis Center, OH | Not verified | Oct 21, 2026 |
| STERILIZATION SERVICES OF GEORGIA, INC. | 1048735 | Contract sterilizer | General and plastic surgery; Cardiovascular; Ear, nose and throat +12 more | Atlanta, GA | Not verified | Oct 21, 2026 |
| STRYKER PUERTO RICO, LLC. | 2648666 | Contract manufacturer | Orthopedic; General and plastic surgery; Ear, nose and throat +2 more | Arroyo, PR | Not verified | Oct 21, 2026 |
| TESCO ASSOCIATES, INC. | 1226183 | Contract manufacturer | Orthopedic; General and plastic surgery; Cardiovascular | Tyngsboro, MA | Not verified | Oct 21, 2026 |
Related orthopedic product codes
- LXH Orthopedic Manual Surgical Instrument (276)
- HWC Screw, Fixation, Bone (215)
- HRS Plate, Fixation, Bone (173)
- MAX Intervertebral Fusion Device With Bone Graft, Lumbar (164)
- NKB Thoracolumbosacral Pedicle Screw System (158)
- KWQ Appliance, Fixation, Spinal Intervertebral Body (156)
- KWP Appliance, Fixation, Spinal Interlaminal (148)
- MNI Orthosis, Spinal Pedicle Fixation (143)