Contract manufacturerLincotek Medical LLC (Vandalia, OH)OhioGeneral and plastic surgeryNeurologyOrthopedicClass IClass II
Lincotek Medical LLC
Contract manufacturer · Vandalia, OH
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3010039400 (openFDA record; or search FDA's registration database)
- FEI number
- 3010039400
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer for export only; Manufacturer; Contract manufacturer
- Owner or operator
- Lincotek Medical, LLC (FDA owner/operator no. 9057128)
- Registered address
- 811 Northwoods Blvd, Vandalia, OH 45377
- Contract listings
- 29 device listings, 32 product codes, first listed Dec 27, 2012
- 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 |
|---|---|---|---|---|---|
| FZX | Guide, Surgical, Instrument | Class I | General and plastic surgery | Contract manufacturing | Dec 29, 2012 |
| GXZ | Electrode, Needle | Class II | Neurology | Contract manufacturing | Jan 30, 2013 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Apr 11, 2018 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Apr 4, 2013 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Class II | Orthopedic | Contract manufacturing | Dec 29, 2012 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Dec 29, 2012 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Apr 4, 2013 |
| HTJ | Gauge, Depth | Class I | Orthopedic | Contract manufacturing | Jun 12, 2018 |
| HTQ | Broach | Class I | Orthopedic | Contract manufacturing | Dec 29, 2012 |
| HWA | Impactor | Class I | Orthopedic | Contract manufacturing | Apr 15, 2015 |
| HWB | Extractor | Class I | Orthopedic | Contract manufacturing | Jan 11, 2017 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Apr 11, 2018 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Class I | General and plastic surgery | Contract manufacturing | Aug 17, 2018 |
| HWT | Template | Class I | Orthopedic | Contract manufacturing | Dec 29, 2012 |
| HXG | Tamp | Class I | Orthopedic | Contract manufacturing | Dec 29, 2012 |
| HXK | Holder, Needle; Orthopedic | Class I | Orthopedic | Contract manufacturing | Sep 6, 2019 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Class II | Orthopedic | Contract manufacturing | Sep 6, 2019 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Jan 30, 2013 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Aug 17, 2018 |
| KRR | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Apr 4, 2013 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Class II | Orthopedic | Contract manufacturing | Dec 29, 2012 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | Class II | Orthopedic | Contract manufacturing | Dec 29, 2012 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Sep 6, 2019 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class II | Orthopedic | Contract manufacturing | Sep 6, 2019 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Class II | Orthopedic | Contract manufacturing | Sep 6, 2019 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | Dec 27, 2012 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class II | Orthopedic | Contract manufacturing | Sep 6, 2019 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | Contract manufacturing | Jan 30, 2013 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Jan 30, 2013 |
| NPJ | Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Apr 4, 2013 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | Contract manufacturing | Apr 10, 2019 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Apr 4, 2013 |