Lincotek Medical LLC

FDA Device Registration & Listing · Vandalia, OH, US · Registration 3010039400

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010039400
FEI Number
3010039400
Entity Name
Lincotek Medical LLC
City/State/Country
Vandalia, OH, US
Establishment Address
811 Northwoods Blvd, Vandalia, OH 45377, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Lincotek Medical, LLC (Owner Number: 9057128)
Owner / Operator Contact Address
3110 Stage Post Dr., Suite 117, Bartlett, TN 38133, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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 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) Dual X Zimmer LGE Modular Junction Nut (00998259902)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2019-09-06
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2019-09-06
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2019-04-10
GAB Needle, Suturing, Disposable General, Plastic Surgery Class 1 878.4800 2010-01-07
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2019-09-06
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2019-09-06
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2019-09-06
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2019-09-06
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2019-09-06
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2012-12-29
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-08-17
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2018-08-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-09-17
HWA Impactor Orthopedic Class 1 888.4540 2015-04-15
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-04-11
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-04-11
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-09-17
JDN Implant, Fixation Device, Spinal Orthopedic Class 2 888.3060 2019-12-16
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2012-12-29
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2012-12-29
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2012-12-29
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2012-12-27
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2023-05-16
HWT Template Orthopedic Class 1 888.4800 2012-12-29
HXK Holder, Needle; Orthopedic Orthopedic Class 1 888.4540 2019-09-06
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2012-12-29
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2012-12-29
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2012-12-29
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2010-01-07
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2019-09-06
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-11-16
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-01-30
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2019-09-06
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2019-09-06
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2019-09-06
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2013-01-30
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2013-01-30

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Lincotek Medical, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3011299238 Lincotek Medical LLC Bartlett, TN, US
3020745236 LINCOTEK MEDICAL, LLC Molalla, OR, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K984202 Howmedica, Inc. HOWMEDICA HUMERAL INTERCALARY SYSTEM 1999-02-05
K142269 Reliance Medical Systems, LLC Reliance Cervical IBF System 2015-06-09
K122085 Omni Surgical, LP Dba Spine360 STINGRAY CERVICAL CAGE 2012-10-17
K120275 Synthes (Usa), LLC SYNTHES ACIS/VERTEBRAL SPACER CR 2012-05-25
K042344 Aesculap, Inc. EXCIA TOTAL HIP SYSTEM 2005-03-16

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0012-2019 Exactech, Inc. 2
Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
Z-0024-2022 Exactech, Inc. 2
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Z-0001-2019 Smith & Nephew, Inc. 2
Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229
Z-0002-2019 Smith & Nephew, Inc. 2
JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149
Z-0003-2017 Zimmer Biomet, Inc. 2
Vanguard 360 Revision Knee System Knee prostheses

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010039400. Last updated year: 2026. Please use registration number 3010039400 when referencing this establishment in official correspondence.
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