Medical Device Manufacturer · US , Largo , FL

Linvatec Biomaterials, Ltd. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2003

Recent clearances: DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H, BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS, SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020

View 5 510(k) Devices ↓

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Linvatec Biomaterials, Ltd. Orthopedic ✕

4 devices

1-4 of 4

Cleared Nov 19, 2004

DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H

Orthopedic · 22d

Cleared Sep 16, 2004

SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020

Orthopedic · 23d

Cleared Apr 16, 2004

CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN FX SCREW PARTIALLY...

Orthopedic · 252d

Cleared Jul 25, 2003

2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445

Orthopedic · 29d