Synthacer T6110TMO-1
by medArtis Medizinprodukte und Forschung Aktiengesellschaft
Synthacer T6110TMO-1 (6.110TMO) is a Class II device made by medArtis Medizinprodukte und Forschung Aktiengesellschaft, cleared under FDA 510(k) K041177 on 23 Jun 2005 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 04250971400934), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04250971400934 | Date24 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK041177 | Date23 Jun 2005 | StatusActive |
Official records
- AccessGUDID record 04250971400934
- FDA 510(k) database K041177
Across registries
- FDA 510(k) K041177 decided 23 Jun 2005 Active
- FDA GUDID UDI-DI 04250971400934 listed 24 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K041177
- Listed FDA GUDID 04250971400934
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Synthacer
- Generic name
- Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobial
- Model / Ref / Catalog
- T6110TMO-1, 6.110TMO
- Primary DI / UDI-DI
- 04250971400934
- 510(k) Number
- 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
- Length — 25 MillimeterOuter Diameter — 12.75 MillimeterPore Size — 300 Micrometer
Similar devices
Other devices filed under FDA product code MQV (Filler, Bone Void, Calcium Compound).
- MOZAIK BONE REGENERATION MATRIX - PUTTY by Integra Lifesciences Corporation
- BIOSORB BIO1 Granules P822692647 by S.B.M
- JGH1 Bone Graft Substitute by AgNovos Healthcare, USA, LLC
- OSFERION by Olympus America, Inc.
- OSSIFUSE BONE SUBSTITUTE MATERIAL by Etex Corp.
- GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES by Berkeley Advanced Biomaterials
- Bicera Resorbable Bone Substitute by WILTROM INC.
- MagnetOs Easypack Putty by Kuros Biosciences B.V
- Agilon Moldable by Biogennix, LLC
- OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM by Biomet Manufacturing Corp
Other devices from medArtis Medizinprodukte und Forschung Aktiengesellschaft
See all devices from medArtis Medizinprodukte und Forschung Aktiengesellschaft →