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
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
Intervertebral Fusion Device With Bone Graft, Cervical ODP
Needle, Suturing, Disposable GAB
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer HSN
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
Intervertebral Fusion Device With Bone Graft, Lumbar MAX
Impactor HWA
Screw, Fixation, Bone HWC
Plate, Fixation, Bone HRS
Implant, Fixation Device, Spinal JDN
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
Orthopedic Manual Surgical Instrument LXH
Template HWT
Holder, Needle; Orthopedic HXK
Guide, Surgical, Instrument FZX
Instrument, Manual, Surgical, General Use MDM
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
Extractor HWB
Broach HTQ
Electrode, Needle GXZ
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
Tamp HXG
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer NPJ
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
Gauge, Depth HTJ
Accessories, Arthroscopic NBH
Orthopedic Stereotaxic Instrument OLO

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