KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT
FDA 510(k) clearance K111970 · decided 2012-02-23
Clearance details
- K-number
- K111970
- Device name
- KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT
- Applicant
- Tornier
- Decision
- Substantially Equivalent
- Date received
- 2011-07-11
- Decision date
- 2012-02-23
- Days to decision
- 227 days
- Clearance type
- Traditional
- Product code
- KRR
- Device class
- 2
- Regulation number
- 888.3540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Saint-Ismier Cedex, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.