Synthacer T6109TMC-1
by medArtis Medizinprodukte und Forschung Aktiengesellschaft
Synthacer T6109TMC-1 (6.109TMC) 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 04250971400903), 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 | Number04250971400903 | Date24 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK041177 | Date23 Jun 2005 | StatusActive |
Official records
- AccessGUDID record 04250971400903
- FDA 510(k) database K041177
Across registries
- FDA 510(k) K041177 decided 23 Jun 2005 Active
- FDA GUDID UDI-DI 04250971400903 listed 24 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K041177
- Listed FDA GUDID 04250971400903
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- Withdrawn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
- T6109TMC-1, 6.109TMC
- Primary DI / UDI-DI
- 04250971400903
- 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
- Pore Size — 300 MicrometerOuter Diameter — 11.55 MillimeterLength — 25 Millimeter
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