V-STRUT Vertebral Implant
FDA 510(k) clearance K191709 · decided 2020-03-05
Clearance details
- K-number
- K191709
- Device name
- V-STRUT Vertebral Implant
- Applicant
- Hyprevention Sas
- Decision
- Substantially Equivalent
- Date received
- 2019-06-26
- Decision date
- 2020-03-05
- Days to decision
- 253 days
- Clearance type
- Traditional
- Product code
- NDN
- Device class
- 2
- Regulation number
- 888.3027
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Pessac Cedex, FR
- Third-party review
- No
- Expedited review
- No
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| V-STRUT® Vertebral Implant (K240084) | Hyprevention | 2024-02-09 |
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| KYPHON VuE Bone Cement (K220131) | Tecres S.P.A. | 2022-04-18 |
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Recalls involving this device
No recalls on record reference this clearance.