TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS
FDA 510(k) clearance K141056 · decided 2014-08-05
Clearance details
- K-number
- K141056
- Device name
- TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS
- Applicant
- Stryker Orthopaedics
- Decision
- Substantially Equivalent
- Date received
- 2014-04-24
- Decision date
- 2014-08-05
- Days to decision
- 103 days
- Clearance type
- Traditional
- Product code
- MBH
- Device class
- 2
- Regulation number
- 888.3565
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mahwah, NJ, US
- Third-party review
- No
- Expedited review
- No
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