OsteoCurrent 56900010

• FDA 510(k) K181958 decided 6 Dec 2018 Active
• FDA GUDID UDI-DI 10889981180508 listed 28 Oct 2019 Listed

1. 6 Dec 2018 Cleared FDA 510(k) K181958
2. 28 Oct 2019 Listed FDA GUDID 10889981180508

Trade name

OsteoCurrent

Generic name

Orthopaedic bone void filling material, synthetic/animal-derived

Model / Ref / Catalog

56900010

Primary DI / UDI-DI

10889981180508

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).

• Synthetic Bone Putty by Ventris Medical
• VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER by Orthovita, Inc.
• CERAMENT IBONE VOID FILLER HIGH CONTRAST, MODEL A 0210-12 by Bonesupport AB
• POLYGRAFT BGS by Smith & Nephew, Inc.
• NovoGro by OSTEONOVUS, INC.
• NuVasive AttraX Scaffold by Nuvasive, Inc.
• MBCP by BIOMATLANTE
• si-Mochi by Biostone, Ltd.
• POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX by Osteobiologics, Inc.
• OSTEOSET DBM PELLETS, MODEL 8600-48XX by Wrightmedicaltechnologyinc

• 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 →