Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System
FDA 510(k) clearance K233509 · decided 2024-04-10
Clearance details
- K-number
- K233509
- Device name
- Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System
- Applicant
- Zavation Medical Products, LLC
- Decision
- Substantially Equivalent
- Date received
- 2023-10-31
- Decision date
- 2024-04-10
- Days to decision
- 162 days
- Clearance type
- Traditional
- Product code
- MAX
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Flowood, MS, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.