Arthrex ABS-2012-05

• FDA 510(k) K040419 decided 25 Mar 2005 Active
• FDA GUDID UDI-DI 10889981153632 listed 17 Nov 2017 Listed

1. 25 Mar 2005 Cleared FDA 510(k) K040419
2. 17 Nov 2017 Listed FDA GUDID 10889981153632

Trade name

Arthrex

Generic name

Human-derived demineralized bone matrix implant

Model / Ref / Catalog

ABS-2012-05

Primary DI / UDI-DI

10889981153632

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).

• Ceracell Ortho Foam by curasan AG
• GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN by Etex Corp.
• OsteoSelect Demineralized Bone Matrix Putty by Bacterin International, Inc.
• Magnifuse Bone Graft (Cleared as Grafton II EDBM) MQV by MEDTRONIC SOFAMOR DANEK, INC.
• GranOSTM - beta tricalcium phosphate synthetic bone granules by Tcm Associates, Ltd.
• NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT by Pioneer Surgical Technology, Inc.
• Pioneer Surgical Nanoss BVF-E by Pioneer Surgical Technology, Inc.
• CureOs TCP by Linacol Muh Dan Kim Cev Tek Med Ith Ihr San VE Tic
• Eovia Calcium Phosphate Ceramic by Ortho Tec, LLC
• ATLANTIK by Medical Biomat

• 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 →