Contract manufacturerCEP BIO-COAT, LLC (Farmington Hills, MI)MichiganOrthopedicClass IIUnclassifiedClass III
CEP BIO-COAT, LLC
Contract manufacturer · Farmington Hills, MI
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3011277306 (openFDA record; or search FDA's registration database)
- FEI number
- 3011277306
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- CEP Bio-Coat, LLC D/B/A Orchid Orthopedic Solutions, LLC (FDA owner/operator no. 10042681)
- Registered address
- 23149 Commerce Drive, Farmington Hills, MI 48335
- Contract listings
- 25 device listings, 22 product codes, first listed Feb 7, 2014
- 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 |
|---|---|---|---|---|---|
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Dec 13, 2024 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Class II | Orthopedic | Contract manufacturing | Dec 13, 2024 |
| JDW | Pin, Fixation, Threaded | Class II | Orthopedic | Contract manufacturing | Dec 13, 2024 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | Class II | Orthopedic | Contract manufacturing | Dec 13, 2024 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | Class II | Orthopedic | Contract manufacturing | Dec 13, 2024 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Class II | Orthopedic | Contract manufacturing | Feb 7, 2014 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | Contract manufacturing | Feb 7, 2014 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Class II | Orthopedic | Contract manufacturing | Dec 13, 2024 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Dec 13, 2024 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class II | Orthopedic | Contract manufacturing | Dec 13, 2024 |
| LZJ | Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained | Unclassified | Orthopedic | Contract manufacturing | Dec 13, 2024 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class II | Orthopedic | Contract manufacturing | Dec 13, 2024 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Dec 13, 2024 |
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | Class II | Orthopedic | Contract manufacturing | Dec 13, 2024 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Class II | Orthopedic | Contract manufacturing | Dec 13, 2024 |
| MJO | Prosthesis, Intervertebral Disc | Class III | Orthopedic | Contract manufacturing | Jun 5, 2018 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Class II | Orthopedic | Contract manufacturing | Feb 7, 2014 |
| MNI | Orthosis, Spinal Pedicle Fixation | Class II | Orthopedic | Contract manufacturing | Feb 7, 2014 |
| MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Class III | Orthopedic | Contract manufacturing | Jun 5, 2018 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | Contract manufacturing | Feb 7, 2014 |
| NQP | Posterior Metal/Polymer Spinal System, Fusion | Class II | Orthopedic | Contract manufacturing | Feb 7, 2014 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Class II | Orthopedic | Contract manufacturing | Feb 7, 2014 |