Synthecure Bone Void Filler Kit, 10cc

• FDA 510(k) K250141 decided 16 May 2025 Active
• FDA GUDID UDI-DI 04262531220029 listed 31 Jul 2025 Listed

1. 16 May 2025 Cleared FDA 510(k) K250141
2. 31 Jul 2025 Listed FDA GUDID 04262531220029

Trade name

Synthecure

Generic name

Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobial

Model / Ref / Catalog

Bone Void Filler Kit, 10cc, 50-010

Primary DI / UDI-DI

04262531220029

510(k) Number

K250141 ↗

FDA product code

MQV

GMDN term

Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobial

Device class

Class II

Regulation number

888.3045

GUDID distribution status

In Commercial Distribution

Category: Bone matrix implant, synthetic, non-antimicrobial

Other devices filed under FDA product code MQV (Filler, Bone Void, Calcium Compound).

• EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE by Etex Corp.
• INQU by Isto Technologies, Inc.
• MagnetOs granules by Kuros Biosciences B.V
• OsteoFlo HydroFiber by SURGENTEC LLC
• BIOSET XCH by Regeneration Technologies, Inc.
• DBX DEMINERALIZED BONE MATRIX PUTTY by Musculoskeletal Transplant Foundation
• JAX by Smith & Nephew, Inc.
• MASTERGRAFT STRIP by MEDTRONIC SOFAMOR DANEK, INC.
• Cerasorb Ortho Foam by curasan AG
• OsteoFlo® HydroPutty™ by SURGENTEC LLC

• Osteopal® V

  Class II

  FDA 510(k) K241674 Active Cleared 5 Dec 2024 GUDID on market

• PALACOS® R+G pro

  Class I

  FDA 510(k) ×2 Active Cleared 5 Sep 2014 GUDID on market

• COPAL® exchange G Trial Set hip S

  Class I

  GUDID on market

• Palacos Lv+g

  Class II

  FDA 510(k) K050854 Active Cleared 7 Jul 2005 GUDID on market

See all devices from Heraeus Medical LLC →