Bojrab 0506
by Medtronic Xomed Inc 3 variants
Bojrab 0506 is a Class II device made by Medtronic Xomed Inc, cleared under FDA 510(k) K904239 on 21 Jun 1991 and listed in FDA GUDID since 15 Jun 2015 (UDI-DI 00681490023764), active as of 8 Nov 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 | Number00681490023764 | Date15 Jun 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK904239 | Date21 Jun 1991 | StatusActive |
Official records
- AccessGUDID record 00681490023764
- FDA 510(k) database K904239
Across registries
- FDA 510(k) K904239 decided 21 Jun 1991 Active
- FDA GUDID UDI-DI 00681490023764 listed 15 Jun 2015 Listed
Timeline
- Cleared FDA 510(k) K904239
- Listed FDA GUDID 00681490023764
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Bojrab
- Generic name
- Ossicular prosthesis, total
- Model / reference
- 0506
- Primary DI / UDI-DI
- 00681490023764
- 510(k) Number
- FDA product code
- ETA
- GMDN term
- Ossicular prosthesis, total
- Device class
- Class II
- Regulation number
- 874.3495
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
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Other devices filed under FDA product code ETA (REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL).
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