Medical Device Manufacturer · US , Waltham , MA

Apatech , Ltd. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2004

8

Total

8

Cleared

0

Denied

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

7 devices

1-7 of 7

Cleared Nov 25, 2008

ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES

Orthopedic · 81d

Cleared Nov 06, 2008

ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTE

Orthopedic · 118d

Cleared Sep 11, 2008

ACTIFUSE FLOW BONE GRAFT SUBSTITUTE

Orthopedic · 50d

Cleared Apr 16, 2008

ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE

Orthopedic · 30d

Cleared May 31, 2007

ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE

Orthopedic · 30d

Cleared Aug 04, 2004

PORE-SI BONE GRAFT SUBSTITUTE

Orthopedic · 202d

Cleared May 07, 2004

APAPORE BONE GRAFT SUBSTITUTE

Orthopedic · 163d