ZUK Select Knee System
FDA 510(k) clearance K160738 · decided 2016-06-15
Clearance details
- K-number
- K160738
- Device name
- ZUK Select Knee System
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-03-17
- Decision date
- 2016-06-15
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- HSX
- Device class
- 2
- Regulation number
- 888.3520
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Cordova, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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|---|---|---|
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