Axis 130-45045
Axis 130-45045 is a Class II device made by Extremity Medical, LLC, cleared under FDA 510(k) K171018 on 13 Jul 2017 and listed in FDA GUDID since 21 Jun 2019 (UDI-DI 00842078112601), 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 | Number00842078112601 | Date21 Jun 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK171018 | Date13 Jul 2017 | StatusActive |
Official records
- AccessGUDID record 00842078112601
- FDA 510(k) database K171018
Across registries
- FDA 510(k) K171018 decided 13 Jul 2017 Active
- FDA GUDID UDI-DI 00842078112601 listed 21 Jun 2019 Listed
Timeline
- Cleared FDA 510(k) K171018
- Listed FDA GUDID 00842078112601
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Axis
- Generic name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile
- Model / reference
- 130-45045
- Primary DI / UDI-DI
- 00842078112601
- 510(k) Number
- FDA product code
- HWC
- GMDN term
- Orthopaedic bone screw, non-bioabsorbable, non-sterile
- Device class
- Class II
- Regulation number
- 888.3040
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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