Medical Device Manufacturer · NL , Bilthoven

Isotis Orthobiologics, Inc. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 2004

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Isotis Orthobiologics, Inc. Orthopedic ✕

7 devices

1-7 of 7

Cleared Aug 10, 2009

Orthopedic · 109d

Cleared Sep 24, 2008

Orthopedic · 90d

Cleared Oct 15, 2007

ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY

Orthopedic · 210d

Cleared Dec 05, 2005

ORTHOBLAST II PUTTY AND PASTE

Orthopedic · 269d

Cleared Sep 07, 2005

CONNEXUS, .5CC, MODEL 023000-005

Orthopedic · 35d

Cleared Jul 07, 2005

Orthopedic · 112d

Cleared Mar 25, 2005

Orthopedic · 401d