Medical Device Manufacturer · US , North Attleboro , MA

Isotis NV - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2000

Recent clearances: ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC, ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY, ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY

View 8 510(k) Devices ↓

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Isotis NV Orthopedic ✕

4 devices

1-4 of 4

Cleared Aug 15, 2007

ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC

Orthopedic · 408d

Cleared May 20, 2003

OSSATURA BCP BONE VOID FILLER

Orthopedic · 126d

Cleared Apr 20, 2001

Orthopedic · 30d

Cleared May 04, 2000

Orthopedic · 72d