Current 02-9000-010

• FDA 510(k) K181958 decided 6 Dec 2018 Active
• FDA GUDID UDI-DI 10889981180461 listed 28 Oct 2019 Listed

1. 6 Dec 2018 Cleared FDA 510(k) K181958
2. 28 Oct 2019 Listed FDA GUDID 10889981180461

Trade name

Current

Generic name

Orthopaedic bone void filling material, synthetic/animal-derived

Model / Ref / Catalog

02-9000-010

Primary DI / UDI-DI

10889981180461

510(k) Number

K181958 ↗

FDA product code

MQV

GMDN term

Orthopaedic bone void filling material, synthetic/animal-derived

Device class

Class II

Regulation number

888.3045

GUDID distribution status

In Commercial Distribution

Category: Bone matrix implant, composite

Other devices filed under FDA product code MQV (FILLER, BONE VOID, CALCIUM COMPOUND).

• JGH1 Bone Graft Substitute by AgNovos Healthcare, USA, LLC
• OSFERION by Olympus America, Inc.
• OSSIFUSE BONE SUBSTITUTE MATERIAL by Etex Corp.
• GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES by Berkeley Advanced Biomaterials
• Bicera Resorbable Bone Substitute by WILTROM INC.
• MagnetOs Easypack Putty by Kuros Biosciences B.V
• Agilon Moldable by Biogennix, LLC
• OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM by Biomet Manufacturing Corp
• Vivorte Trabexus by Vivorte, Inc
• JAX GRANULES BONE VOID FILLER by Smith & Nephew, Inc.

• OsteoStrux Putty 56070050

  Class II

  FDA 510(k) K062353 Active Cleared 20 Dec 2006 GUDID on market

• OsteoBallast 56800060 Open recall

  Class II

  FDA 510(k) K172130 Active Cleared 16 Nov 2017 GUDID on market

• Current 02-9000-100

  Class II

  FDA 510(k) K181958 Active Cleared 6 Dec 2018 GUDID on market

• OsteoSurge 100 Putty 56300100

  Class II

  FDA 510(k) K061880 Active Cleared 15 Aug 2007 GUDID on market

See all devices from Isotis Orthobiologics, Inc →