Contract manufacturerSCT, INC. (Franklin Lakes, NJ)New JerseyOrthopedicGeneral and plastic surgeryNeurologyClass IIClass I
SCT, INC.
Contract manufacturer ยท Franklin Lakes, NJ
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2249615 (openFDA record; or search FDA's registration database)
- FEI number
- 3001049282
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- SCT, INC. (FDA owner/operator no. 9040558)
- Registered address
- 509 Commerce St, Franklin Lakes, NJ 07417
- Contract listings
- 33 device listings, 45 product codes, first listed Feb 25, 2013
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Mar 26, 2013 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Mar 26, 2013 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Class II | Orthopedic | Contract manufacturing | Mar 26, 2013 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Class II | Orthopedic | Contract manufacturing | Feb 26, 2013 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Feb 26, 2013 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Mar 26, 2013 |
| HTO | Reamer | Class I | Orthopedic | Contract manufacturing | Feb 26, 2013 |
| HTW | Bit, Drill | Class I | Orthopedic | Contract manufacturing | Feb 26, 2013 |
| HTY | Pin, Fixation, Smooth | Class II | Orthopedic | Contract manufacturing | Mar 26, 2013 |
| HWA | Impactor | Class I | Orthopedic | Contract manufacturing | Mar 4, 2013 |
| HWB | Extractor | Class I | Orthopedic | Contract manufacturing | Mar 4, 2013 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Mar 26, 2013 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Class I | General and plastic surgery | Contract manufacturing | Jun 12, 2018 |
| HWJ | Awl | Class I | Orthopedic | Contract manufacturing | Feb 26, 2013 |
| HWX | Tap, Bone | Class I | Orthopedic | Contract manufacturing | Feb 26, 2013 |
| HXC | Wrench | Class I | Orthopedic | Contract manufacturing | Feb 26, 2013 |
| JDC | Prosthesis, Elbow, Constrained, Cemented | Class II | Orthopedic | Contract manufacturing | Feb 11, 2021 |
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | Class II | Orthopedic | Contract manufacturing | Mar 9, 2015 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Class II | Orthopedic | Contract manufacturing | Mar 9, 2015 |
| JDJ | Mesh, Surgical, Acetabular, Hip, Prosthesis | Class II | General and plastic surgery | Contract manufacturing | Mar 9, 2015 |
| JDO | Device, Fixation, Proximal Femoral, Implant | Class II | Orthopedic | Contract manufacturing | Mar 26, 2013 |
| JDQ | Cerclage, Fixation | Class II | Orthopedic | Contract manufacturing | Mar 9, 2015 |
| JDS | Nail, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Mar 26, 2013 |
| JDW | Pin, Fixation, Threaded | Class II | Orthopedic | Contract manufacturing | Mar 26, 2013 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Feb 25, 2013 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Mar 26, 2013 |
| KRQ | Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Mar 26, 2013 |
| KRR | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Mar 26, 2013 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Class II | Orthopedic | Contract manufacturing | Mar 26, 2013 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | Class II | Orthopedic | Contract manufacturing | Mar 9, 2015 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Class II | Orthopedic | Contract manufacturing | Feb 26, 2013 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | Class II | Orthopedic | Contract manufacturing | Feb 26, 2013 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Class II | Orthopedic | Contract manufacturing | Mar 9, 2015 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Mar 9, 2015 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class II | Orthopedic | Contract manufacturing | Feb 25, 2013 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Class II | Orthopedic | Contract manufacturing | Mar 9, 2015 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | Feb 25, 2013 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class II | Orthopedic | Contract manufacturing | Mar 26, 2013 |
| LZY | Prosthesis, Hip, Hemi-, Femoral, Metal Ball | Class II | Orthopedic | Contract manufacturing | Mar 9, 2015 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Feb 25, 2013 |
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | Class II | Orthopedic | Contract manufacturing | Mar 26, 2013 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Class II | Orthopedic | Contract manufacturing | Mar 26, 2013 |
| NPJ | Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Mar 26, 2013 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Mar 26, 2013 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Class II | Orthopedic | Contract manufacturing | Feb 26, 2013 |