Data / Medical devices / United States / Lincotek Medical LLC
Lincotek Medical LLC: FDA-registered device maker in Vandalia, OH, United States, 1 510(k) clearance
Lincotek Medical LLC is registered with the FDA (registration 3010039400) in Vandalia, OH, United States. It lists 36 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 2, 2011. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3010039400
- Address
- 811 Northwoods Blvd, Vandalia, OH, United States, 45377
- Owner or operator
- Lincotek Medical, LLC (9057128)
- Roles
- Contract manufacturer, Manufacturer, Manufacturer for export
- First device listed
- January 7, 2010
- Registered through
- 2026
- Brand names listed
- Depuy Ortho 240433050 AGILITY LP TIB INSRT TRL SZ3/2 AGILITY LP TIB INSRT TRL SZ3/2 PSV, Dual X, Zimmer BF Humeral Head 15mm x 40mm (430054015), Zimmer BF Humeral Head 18mm x 40mm (430054018), Zimmer BF Humeral Head 18mm x 46mm (430054618), Zimmer BF Humeral Head 21mm x 46mm (430054621), Zimmer BF Humeral Head 21mm x 52mm (430055221), Zimmer BF Humeral Head 24mm x 46mm (430054624) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Accessories, Arthroscopic | NBH | 1 | Manufacturer | accessdata.fda.gov |
| Broach | HTQ | 1 | Contract manufacturer | accessdata.fda.gov |
| Electrode, Needle | GXZ | 2 | Contract manufacturer | accessdata.fda.gov |
| Extractor | HWB | 1 | Contract manufacturer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Contract manufacturer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Contract manufacturer | accessdata.fda.gov |
| Holder, Needle; Orthopedic | HXK | 1 | Contract manufacturer | accessdata.fda.gov |
| Impactor | HWA | 1 | Contract manufacturer | accessdata.fda.gov |
| Implant, Fixation Device, Spinal | JDN | 2 | Manufacturer for export | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | 1 | Contract manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Contract manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Contract manufacturer | accessdata.fda.gov |
| Needle, Suturing, Disposable | GAB | 1 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Contract manufacturer | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | Contract manufacturer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Contract manufacturer | accessdata.fda.gov |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | 2 | Contract manufacturer | accessdata.fda.gov |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | 2 | Contract manufacturer | accessdata.fda.gov |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | 2 | Contract manufacturer | accessdata.fda.gov |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | 2 | Contract manufacturer | accessdata.fda.gov |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | 2 | Contract manufacturer | accessdata.fda.gov |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | 2 | Contract manufacturer | accessdata.fda.gov |
| Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | NPJ | 2 | Contract manufacturer | accessdata.fda.gov |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | 2 | Contract manufacturer | accessdata.fda.gov |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | 2 | Contract manufacturer | accessdata.fda.gov |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | 2 | Contract manufacturer | accessdata.fda.gov |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | 2 | Contract manufacturer | accessdata.fda.gov |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | 2 | Contract manufacturer | accessdata.fda.gov |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | 2 | Contract manufacturer | accessdata.fda.gov |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | 2 | Contract manufacturer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Contract manufacturer | accessdata.fda.gov |
| Tamp | HXG | 1 | Contract manufacturer | accessdata.fda.gov |
| Template | HWT | 1 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|
| September 2, 2011 | K110791 | BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION | KWT | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 2, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.