Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008421730

FEI Number

3008421730

Entity Name

Lincotek Medical

City/State/Country

Bartlett, TN, US

Establishment Address

3110 Stage Post Dr Ste 117, Bartlett, TN 38133, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Surface Dynamics LLC (Owner Number: 10047928)

Owner / Operator Contact Address

3110 Stage Post Dr Ste 101, Bartlett, TN 38133, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AVL HINGE KNEE SYSTEM M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE In Bone RINGLOC + HYBRID ACETABULAR SYSTEM ONCOLOGY SALVAGE SYSTEM POROUS COATED ACETABULAR COMPONENTS POROUS COATED COMPREHENSIVE FRACTURE STEMS ORTHOPEDIC SALVAGE SYSTEM - OSS REDUCED SIZE ONCOLOGY SALVAGE SYSTEM M2A MAGNUM SYSTEM Comprehensive Primary Stem RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) MALLORY- HEAD TOTAL HIP SYSTEM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2019-08-02
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Orthopedic	Class 3	888.3330	2019-03-11
KWI	Prosthesis, Elbow, Hemi-, Radial, Polymer	Orthopedic	Class 2	888.3170	2019-08-02
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2014-11-17
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Orthopedic	Class 3	888.3330	2019-03-11
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Orthopedic	Class 3	888.3330	2016-05-16
JDL	Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)	Orthopedic	Class 3	888.3320	2016-05-16
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2019-08-02
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Orthopedic	Class 3	888.3330	2019-03-11
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2019-08-12
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2019-08-02
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2019-08-02
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Orthopedic	Class 3	888.3330	2019-03-11
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2018-02-19
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2019-08-02
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2019-03-11

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Surface Dynamics LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K220628	Waldemar Link GmbH & Co. KG	LINK Endo-Model EVO Knee System	2022-05-03
K080663	Wrightmedicaltechnologyinc	PROFEMUR LX REVISION 5/8 COATED HIP STEM	2008-04-08
K851213	Allo Pro Corp.	ZWEYMULLER CUP	1985-05-28
K854107	Kirschner Medical Corp.	DIMENSION TOTAL HIP PROSTHESIS POROUS COATED	1986-03-10
K141345	Tornier S.A.S.	AEQUALIS FX2	2014-11-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2023	Wright Medical Technology, Inc.	2	stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.
Z-0006-2023	Wright Medical Technology, Inc.	2	stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008421730. Last updated year: 2026. Please use registration number 3008421730 when referencing this establishment in official correspondence.