Baha 93357
by Cochlear Bone Anchored Solutions AB
Baha 93357 is a Class II device made by Cochlear Bone Anchored Solutions AB, cleared under FDA 510(k) K121317 on 12 Oct 2012 and listed in FDA GUDID since 22 Oct 2015 (UDI-DI 09321502033435), 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 | Number09321502033435 | Date22 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK121317 | Date12 Oct 2012 | StatusActive |
Official records
- AccessGUDID record 09321502033435
- FDA 510(k) database K121317
Across registries
- FDA 510(k) K121317 decided 12 Oct 2012 Active
- FDA GUDID UDI-DI 09321502033435 listed 22 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K121317
- Listed FDA GUDID 09321502033435
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Baha
- Generic name
- Craniofacial bone screw, non-bioabsorbable
- Model / Ref / Catalog
- 93357
- Primary DI / UDI-DI
- 09321502033435
- 510(k) Number
- FDA product code
- MAH
- GMDN term
- Craniofacial bone screw, non-bioabsorbable
- Device class
- Class II
- Regulation number
- 874.3302
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Radiation Sterilization
- MRI safety
- MR Conditional
- Size
- Length — 12 Millimeter
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