Lincotek Medical LLC

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3010039400	3010039400	Lincotek Medical LLC	1	N	2026-01-01	811 Northwoods Blvd Vandalia OH US 45377
3011299238	3011299238	Lincotek Medical LLC	1	N	2026-01-01	3110 Stage Post Dr Ste 117 Bartlett TN US 38133

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
B57112520006030D0	Integrity-SI Fusion System - 6.5 x 30 mm Biomechanical Screw	435-753-7675	tcannefax@coorstekmedical.com

coorstekmedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
176350	1685157729	K132735	AXIA RADIAL HEAD SYSTEM	KWI	2014-01-07
150874	1942107431	K110791	BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION	KWT	2011-09-02
150874	1607631543
150874	1012358655
150874	1021618283
176350	1034983635
150874	1034983635
150874	1040325100
150874	1053608583
150874	1060458814
150874	1060667698
150874	1073291869
150874	1157905555
150874	1158835958
150874	1252891749
176350	1252891749
150874	1321077999
150874	1321126129
150874	1322228423
150874	1325289512
150874	1329141364
150874	1405095959
176350	1432405361
150874	1432405361
150874	1485456457
150874	1506980882
150874	1551634444
150874	1557302569
150874	1590014100
150874	1590489589
150874	1596367903
150874	1629715172
150874	1631180937
150874	1701644776
150874	1716628113
150874	1791212091
150874	1808988980
150874	1950178966
150874	1962803093

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
KWI	1	2014-01-07
KWT	1	2011-09-02

GUDID#

Versipass Suture Passer Needle - Suture passer needle for the Versipass Suture Passer
Lincotek Medical LLC
2024-10-17
Champion Suture Passer Ratchet Straight - 3910-900-086
Lincotek Medical LLC
2024-01-02
Champion Suture Passer Ratchet Humpback - 3910-900-087
Lincotek Medical LLC
2024-01-02
Champion Suture Passer Ratchet Straight Capture - 3910-900-088
Lincotek Medical LLC
2024-01-02
Champion Suture Passer Ratchet Humpback Capture - 3910-900-089
Lincotek Medical LLC
2024-01-02
Champion Suture Passer Needle - Champion Passer Needle - single needle
Lincotek Medical LLC
2023-12-18
Versipass Suture Passer - The VersiPass Suture Passer instrument is a reusable manual surgical instrument used to pass sutures for arthroscopic and open repair of soft tissues.
Lincotek Medical LLC
2023-12-12
Integrity-SI Fusion System - 6.5 x 30 mm Biomechanical Screw
Lincotek Medical LLC
2018-07-09
Integrity-SI Fusion System - 6.5 x 35 mm Biomechanical Screw
Lincotek Medical LLC
2018-07-09
Integrity-SI Fusion System - 6.5 x 40 mm Biomechanical Screw
Lincotek Medical LLC
2018-07-09
Integrity-SI Fusion System - 6.5 x 45 mm Biomechanical Screw
Lincotek Medical LLC
2018-07-09
Integrity-SI Fusion System - 6.5 x 50 mm Biomechanical Screw
Lincotek Medical LLC
2018-07-09
Integrity-SI Fusion System - 6.5 x 55 mm Biomechanical Screw
Lincotek Medical LLC
2018-07-09
Integrity-SI Fusion System - 6.5 x 60 mm Biomechanical Screw
Lincotek Medical LLC
2018-07-09
Integrity-SI Fusion System - 6.5 x 65 mm Biomechanical Screw
Lincotek Medical LLC
2018-07-09
Integrity-SI Fusion System - 6.5 x 70 mm Biomechanical Screw
Lincotek Medical LLC
2018-07-09
Integrity-SI Fusion System - 10 x 40 mm Anodized SI Implant
Lincotek Medical LLC
2018-07-09
Integrity-SI Fusion System - 10 x 40 mm SI Implant with HA Coating
Lincotek Medical LLC
2018-07-09
Integrity-SI Fusion System - 10 x 45 mm Anodized SI Implant
Lincotek Medical LLC
2018-07-09
Integrity-SI Fusion System - 10 x 45 mm SI Implant with HA Coating
Lincotek Medical LLC
2018-07-09
Integrity-SI Fusion System - 10 x 50 mm Anodized SI Implant
Lincotek Medical LLC
2018-07-09
Integrity-SI Fusion System - 10 x 50 mm SI Implant with HA Coating
Lincotek Medical LLC
2018-07-09
Integrity-SI Fusion System - 10 x 55 mm Anodized SI Implant
Lincotek Medical LLC
2018-07-09
Integrity-SI Fusion System - 10 x 55 mm SI Implant with HA Coating
Lincotek Medical LLC
2018-07-09
Integrity-SI Fusion System - 10 x 60 mm Anodized SI Implant
Lincotek Medical LLC
2018-07-09
Integrity-SI Fusion System - 10 x 60 mm SI Implant with HA Coating
Lincotek Medical LLC
2018-07-09
Integrity-SI Fusion System - 10 x 65 mm Anodized SI Implant
Lincotek Medical LLC
2018-07-09
Integrity-SI Fusion System - 10 x 65 mm SI Implant with HA Coating
Lincotek Medical LLC
2018-07-09
Integrity-SI Fusion System - 10 x 70 mm Anodized SI Implant
Lincotek Medical LLC
2018-07-09
Integrity-SI Fusion System - 10 x 70 mm SI Implant with HA Coating
Lincotek Medical LLC
2018-07-09
Integrity-SI Fusion System - 10 x 75 mm Anodized SI Implant
Lincotek Medical LLC
2018-07-09
Integrity-SI Fusion System - 10 x 75 mm SI Implant with HA Coating
Lincotek Medical LLC
2018-07-09
Integrity-SI Fusion System - 10 x 80 mm Anodized SI Implant
Lincotek Medical LLC
2018-07-09
Integrity-SI Fusion System - 10 x 80 mm SI Implant with HA Coating
Lincotek Medical LLC
2018-07-09
Integrity-SI Fusion System - 10 x 85 mm Anodized SI Implant
Lincotek Medical LLC
2018-07-09
Integrity-SI Fusion System - 10 x 85 mm SI Implant with HA Coating
Lincotek Medical LLC
2018-07-09
Integrity-SI Fusion System - 10 x 90 mm Anodized SI Implant
Lincotek Medical LLC
2018-07-09
Integrity-SI Fusion System - 10 x 90 mm SI Implant with HA Coating
Lincotek Medical LLC
2018-07-09
Integrity-SI Fusion System - 10 x 95 mm Anodized SI Implant
Lincotek Medical LLC
2018-07-09
Integrity-SI Fusion System - 10 x 95 mm SI Implant with HA Coating
Lincotek Medical LLC
2018-07-09

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