Prosthesis, Toe, Constrained, Polymer (KWH) contract manufacturers
14 US facilities list FDA product code KWH as a contract manufacturer (5) or contract sterilizer (9).
FDA-registered (openFDA, export of Oct 21, 2026)
- FDA device name
- Prosthesis, Toe, Constrained, Polymer
- Product code
- KWH (FDA product classification database)
- Device class
- Class II
- Regulation
- 21 CFR 888.3720
- Classification panel
- Orthopedic
- FDA flags
- implant
Where they are
Illinois 3 · Minnesota 2 · Arizona 1 · Connecticut 1 · Georgia 1 · Indiana 1 · Michigan 1 · New Jersey 1 · Ohio 1 · Pennsylvania 1 · Texas 1
All 14 facilities
| Company | FDA registration | Establishment type | Device categories | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| 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. | 1424263 | Contract sterilizer | Orthopedic; General and plastic surgery; Ophthalmic +13 more | Libertyville, IL | 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 |
| Isomedix Operations, Inc. | 2183744 | Contract sterilizer | Cardiovascular; General and plastic surgery; Gastroenterology and urology +13 more | Minneapolis, MN | Not verified | Oct 21, 2026 |
| MEDICAL DEVICE AND IMPLANTS LLC | 3009826895 | Contract manufacturer | Orthopedic | Lancaster, PA | Not verified | Oct 21, 2026 |
| MICROPULSE INC | 1834379 | Contract manufacturer | Orthopedic; General and plastic surgery; Neurology +1 more | Columbia City, IN | Not verified | Oct 21, 2026 |
| ORCHID UNIQUE | 1828288 | Contract manufacturer | Orthopedic; General and plastic surgery; Dental +3 more | Bridgeport, MI | Not verified | Oct 21, 2026 |
| QUALITY TECH SERVICES, LLC | 3003477135 | Contract manufacturer | Orthopedic; General and plastic surgery; Neurology +11 more | Bloomington, MN | 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 |
| Sterigenics U.S., LLC | 1018470 | Contract sterilizer | General and plastic surgery; Orthopedic; General hospital +12 more | Atlanta, GA | Not verified | Oct 21, 2026 |
| Sterigenics US LLC | 1423662 | Contract sterilizer | Orthopedic; General and plastic surgery; General hospital +14 more | Gurnee, IL | Not verified | Oct 21, 2026 |
| Sterigenics US LLC | 1649518 | Contract sterilizer | Orthopedic; General and plastic surgery; General hospital +13 more | Fort Worth, TX | 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 |
| Stryker Sustainability Solutions Phoenix | 2090040 | Contract sterilizer | Orthopedic; General and plastic surgery; General hospital | Phoenix, AZ | Not verified | Oct 21, 2026 |
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