510(k) K121029
K121029 is an FDA 510(k) premarket notification submitted by Stanmore Implants Worldwide , Ltd. for the device "METS MODULAR DISTAL FEMUR". The FDA issued a decision of Substantially Equivalent on Sep 19, 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 7 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 19, 2012
- Date Received
- Apr 5, 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
- 510(k)