Arthrex ABS-2012-10

• FDA 510(k) K040419 decided 25 Mar 2005 Active
• FDA GUDID UDI-DI 10889981153649 listed 17 Nov 2017 Listed

1. 25 Mar 2005 Cleared FDA 510(k) K040419
2. 17 Nov 2017 Listed FDA GUDID 10889981153649

Trade name

Arthrex

Generic name

Human-derived demineralized bone matrix implant

Model / Ref / Catalog

ABS-2012-10

Primary DI / UDI-DI

10889981153649

510(k) Number

K040419 ↗

FDA product code

MQV

GMDN term

Human-derived demineralized bone matrix implant

Device class

Class II

Regulation number

888.3045

GUDID distribution status

In Commercial Distribution

Category: Bone matrix implant, human-derived

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

• OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE + CCC BONE VOID FILLER (1CC, 2CC, 5CC, 10CC, by Exactech, Inc.
• Resorbable Mesh Device by SeaSpine Orthopedics Corporation
• PRO OSTEON 500R by Ebi, L.P.
• GENEROS 80, GENEROS 60 by Berkeley Advanced Biomaterials
• NOVABONE-RESORBABLE BONE GRAFT SUBSTITUTE by NovaBone Products, LLC
• OSSIPRO BONE SUBSTITUTE MATERIAL by Etex Corp.
• CALLOS IMPACT AND INJECT BONE VOID FILLER by SKELETAL KINETICS LLC
• BONESOURCE BVF by Howmedica Osteonics Corp.
• Montage-XT Settable, Resorbable Bone Putty by Orthocon, Inc.
• VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER by Orthovita, 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 →