VYRSA Fix VYFI-07-050
VYRSA Fix VYFI-07-050 is a Class II device made by Vyrsa Technologies, cleared under FDA 510(k) K162121 on 18 Jan 2017 and listed in FDA GUDID since 27 Jan 2024 (UDI-DI G418VYFI070500), 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 | NumberG418VYFI070500 | Date27 Jan 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK162121 | Date18 Jan 2017 | StatusActive |
Official records
- FDA 510(k) database K162121
Across registries
- FDA 510(k) K162121 decided 18 Jan 2017 Active
- FDA GUDID UDI-DI G418VYFI070500 listed 27 Jan 2024 Listed
Timeline
- Cleared FDA 510(k) K162121
- Listed FDA GUDID G418VYFI070500
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- VYRSA Fix
- Generic name
- Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated
- Model / reference
- VYFI-07-050
- Primary DI / UDI-DI
- G418VYFI070500
- 510(k) Number
- FDA product code
- OUR
- GMDN term
- Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated
- 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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Other devices filed under FDA product code OUR (Sacroiliac Joint Fixation).
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