Radian 5554530
Radian 5554530 is a device classified as Unclassified made by NuVasive, LLC, cleared under FDA 510(k) K101284 on 15 Jul 2010 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00887517255754), active as of 22 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 | Number00887517255754 | Date24 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK101284 | Date15 Jul 2010 | StatusActive |
Official records
- AccessGUDID record 00887517255754
- FDA 510(k) database K101284
Across registries
- FDA 510(k) K101284 decided 15 Jul 2010 Active
- FDA GUDID UDI-DI 00887517255754 listed 24 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K101284
- Listed FDA GUDID 00887517255754
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Radian
- Generic name
- Spinal bone screw, non-bioabsorbable
- Model / reference
- 5554530
- Primary DI / UDI-DI
- 00887517255754
- 510(k) Number
- FDA product code
- MRW
- GMDN term
- Spinal bone screw, non-bioabsorbable
- Device class
- U
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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