FDA Registration
Active
🇺🇸 United States
Lincotek Medical LLC
Reg #: 3010039400
·
FEI: 3010039400
·
Expires 2026
Products
36
Proprietary Names
36
Establishment Types
3
Classifications
36
Registration Details
- Registration Name
- Lincotek Medical LLC
- Registration Number
- 3010039400
- FEI Number
- 3010039400
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 811 Northwoods Blvd
- City
- Vandalia
- State
- OH
- ZIP
- 45377
- Country
- US
Regulatory Submissions
- 510(k) Number
- K110791
Owner / Operator
- Firm Name
- Lincotek Medical, LLC
- Operator Number
- 9057128
- Address
- 3110 Stage Post Dr., Suite 117
- City
- Bartlett
- State
- TN
- Postal Code
- 38133
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2019-09-06 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2019-09-06 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2019-04-10 |
| Needle, Suturing, Disposable | GAB | Class 1 | General, Plastic Surgery | No | 2010-01-07 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2019-09-06 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2019-09-06 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2019-09-06 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2019-09-06 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2019-09-06 |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2012-12-29 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2018-08-17 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2018-08-17 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2025-09-17 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2015-04-15 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2018-04-11 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2018-04-11 |
| Implant, Fixation Device, Spinal | JDN | Class 2 | Orthopedic | No | 2019-12-16 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2012-12-29 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2012-12-27 |
| Template | HWT | Class 1 | Orthopedic | No | 2012-12-29 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2019-09-06 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2012-12-29 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2010-01-07 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2013-01-30 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2017-01-11 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2012-12-29 |
| Electrode, Needle | GXZ | Class 2 | Neurology | No | 2013-01-30 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2018-08-17 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2012-12-29 |
| Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | NPJ | Class 2 | Orthopedic | No | 2013-04-04 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2013-04-04 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2013-04-04 |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2013-04-04 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2018-06-12 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2023-12-05 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2013-04-04 |
Proprietary Names
Zimmer BF Humeral Stem 12mm x 130mm (430051213)
Zimmer BF Humeral Stem 6mm x 130mm (430050613)
Zimmer BF Humeral Stem 16mm x 130mm (430051613)
Zimmer BF Humeral Stem 14mm x 130mm (430051413)
Zimmer BF Humeral Stem 6mm x 60mm (430050606)
Zimmer BF Humeral Head 18mm x 46mm (430054618)
Zimmer BF Humeral Stem 13mm x 130mm (430051313)
Zimmer BF Humeral Head 21mm x 46mm (430054621)
Zimmer BF Humeral Head 27mm x 52mm (430055227)
Zimmer BF Humeral Stem 11mm x 130mm (430051113)
Zimmer BF Humeral Head 21mm x 52mm (430055221)
Zimmer BF Humeral Stem 8mm x 170mm (430050817)
Zimmer BF Humeral Head 18mm x 40mm (430054018)
Zimmer BF Humeral Stem 7mm x 130mm (430050713)
Zimmer BF Humeral Head 15mm x 40mm (430054015)
Zimmer BF Humeral Stem 10mm x 170mm (430051017)
Zimmer BF Humeral Head 30mm x 52mm (430055230)
Zimmer BF Humeral Head 24mm x 46mm (430054624)
Zimmer BF Humeral Head 24mm x 52mm (430055224)
Zimmer BF Humeral Stem 7mm x 60mm (430050706)
Zimmer BF Humeral Stem 10mm x 130mm (430051013)
Zimmer BF Humeral Stem 15mm x 130mm (430051513)
Zimmer BF Humeral Stem 9mm x 130mm (430050913)
Zimmer BF Humeral Stem 8mm x 200mm (430050820)
Zimmer LGE Modular Junction Nut (00998259902)
Zimmer Biomet TM ANKLE IMPACTOR HANDLE LMD
Zimmer Biomet TM ANKLE IMPACTOR HEAD LMD
Zimmer NexGen Tibial and Femoral Augments LCCK FEM PROV/CUT GUIDE SIZE G R (00-5995-017-02)
Zimmer NexGen Tibial and Femoral Augments LCCK FEM PROV/CUT GUIDE SIZE G L (00-5995-017-01)
Dual X
Depuy Ortho 240433050 AGILITY LP TIB INSRT TRL SZ3/2 AGILITY LP TIB INSRT TRL SZ3/2 PSV
Zimmer ECT Mini Connect Screw Holder (00231051500)
Zimmer Tibial Bushing Remover (00588155500) DMAN
Zimmer Femoral Head Extractor (00455600100) DMAN
Zimmer Spring Screw, Short (4/BX) (00-5967-033-01)
Zimmer HGP II Shell Depth Gauge (00-6611-098-00)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Manufacture Device in the United States for Export Only