Rebel 3DKNEE System
FDA 510(k) clearance K143242 · decided 2015-05-15
Clearance details
- K-number
- K143242
- Device name
- Rebel 3DKNEE System
- Applicant
- Encore Medical L.P.
- Decision
- Substantially Equivalent
- Date received
- 2014-11-12
- Decision date
- 2015-05-15
- Days to decision
- 184 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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