Panama™
Panama™ (08-0145-020) is a Class II device made by Flospine, cleared under FDA 510(k) K210182 on 7 Apr 2021 and listed in FDA GUDID since 26 Aug 2021 (UDI-DI B1830801450200), 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 | NumberB1830801450200 | Date26 Aug 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK210182 | Date7 Apr 2021 | StatusActive |
Official records
- FDA 510(k) database K210182
Across registries
- FDA 510(k) K210182 decided 7 Apr 2021 Active
- FDA GUDID UDI-DI B1830801450200 listed 26 Aug 2021 Listed
Timeline
- Cleared FDA 510(k) K210182
- Listed FDA GUDID B1830801450200
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Spinal fixation plate, non-bioabsorbable
- Model / Ref / Catalog
- Panama™, 08-0145-020
- Primary DI / UDI-DI
- B1830801450200
- 510(k) Number
- FDA product code
- KWQ
- GMDN term
- Spinal fixation plate, non-bioabsorbable
- Device class
- Class II
- Regulation number
- 888.3060
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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