510(k) K120992
K120992 is an FDA 510(k) premarket notification submitted by Stanmore Implants Worldwide , Ltd. for the device "METS SMILES TOTAL KNEE REPLACEMENT". The FDA issued a decision of Substantially Equivalent on September 5, 2012. The device falls under product code KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3510. Stanmore Implants Worldwide , Ltd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 5, 2012
- Date Received
- April 2, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3510
- Review Panel
- OR
- Submission Type