Medical Device Manufacturer · US , Atlanta , GA

Medshape Solutions - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2009

Recent clearances: DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000, SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) SOFT TISSUE FASTNER, WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES

View 5 510(k) Devices ↓

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Medshape Solutions General & Plastic Surgery ✕

2 devices

1-2 of 2

Cleared Sep 16, 2009

WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES,MODEL 1000-01...

General & Plastic Surgery · 145d

Cleared Mar 25, 2009

WEDGELOC SUTURE ANCHOR WITH OPTI-FIBER SUTURES, MODEL 1000-01-055

General & Plastic Surgery · 96d