Current 02-9000-025

• FDA 510(k) K181958 decided 6 Dec 2018 Active
• FDA GUDID UDI-DI 10889981180478 listed 28 Oct 2019 Listed

1. 6 Dec 2018 Cleared FDA 510(k) K181958
2. 28 Oct 2019 Listed FDA GUDID 10889981180478

Trade name

Current

Generic name

Orthopaedic bone void filling material, synthetic/animal-derived

Model / Ref / Catalog

02-9000-025

Primary DI / UDI-DI

10889981180478

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).

• VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTE by Orthovita, Inc.
• MagnetOs Putty by Kuros Biosciences B.V
• PRO-DENSE LoVisc Bone Graft Substitute by Wrightmedicaltechnologyinc
• BIO 1-KIT BIOSORB FILLED CARTRIDGE by Science For Biomaterials
• DB-EZ Bone Void Filler by DIMENSIONAL BIOCERAMICS, LLC
• MTF NEW BONE VOID FILLER by Musculoskeletal Transplant Foundation
• MASTERGRAFT RESORBABLE CERAMIC GRANULES by MEDTRONIC SOFAMOR DANEK, INC.
• POLYGRAFT BONE GRAFT SUBSTITUTE by Osteobiologics, Inc.
• OSTEO-G BONE VOID FILLER SYSTEM by Aspine USA, Inc.
• MCS Bone Graft by Biostructures

• 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 →