Synthacer T6102TMC-1

• FDA 510(k) K041177 decided 23 Jun 2005 Active
• FDA GUDID UDI-DI 04250971400767 listed 24 Oct 2017 Listed

1. 23 Jun 2005 Cleared FDA 510(k) K041177
2. 24 Oct 2017 Listed FDA GUDID 04250971400767

Trade name

Synthacer

Generic name

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

Model / Ref / Catalog

T6102TMC-1, 6.102TMC

Primary DI / UDI-DI

04250971400767

510(k) Number

K041177 ↗

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

Size

Pore Size — 300 Micrometer

Outer Diameter — 4.55 Millimeter

Length — 15 Millimeter

Category: Bone matrix implant, synthetic, non-antimicrobial

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

• Acceli DBM Family Products, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC by Isotis NV
• Actifuse Shape Bone Graft Substitute by Apatech Ltd
• Genex Putty by BIOCOMPOSITES LTD
• Bio2 CLM BG Bioactive Scaffold by BIO2 TECHNOLOGIES, INC.
• OsteoFlo HydroFiber by SURGENTEC LLC
• OSferion by Olympus Terumo Biomaterials Corporation
• COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X, 3X, 6X (1, 3 OR 6 STRIPS PER BOX) by Neucoll, Inc.
• AttraX Scaffold by Nu Vasive, Incorporated
• Calcigen PSI Bone Graft Substitute by Biomet Orthopedics, Inc.
• Altapore Shape by Baxter Healthcare Corp

• Synthacer T6N205TMC-1

  Class II

  FDA 510(k) K041177 Active Cleared 23 Jun 2005 GUDID on market

• Synthacer T6109TMC-1

  Class II

  FDA 510(k) K041177 Active Cleared 23 Jun 2005 GUDID on market

• Synthacer T6N206TMC-1

  Class II

  FDA 510(k) K041177 Active Cleared 23 Jun 2005 GUDID on market

• Synthacer/Syntricer T672G01-2-1

  Class II

  FDA 510(k) K041177 Active Cleared 23 Jun 2005 GUDID on market

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