INTEGRA TOTAL WRIST FUSION SYSTEM
FDA 510(k) clearance K093163 · decided 2009-12-15
Clearance details
- K-number
- K093163
- Device name
- INTEGRA TOTAL WRIST FUSION SYSTEM
- Applicant
- Integra LifeSciences Corporation
- Decision
- Substantially Equivalent
- Date received
- 2009-10-06
- Decision date
- 2009-12-15
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Planisboro, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.