510(k) K133152
K133152 is an FDA 510(k) premarket notification submitted by Stanmore Implants Worldwide , Ltd. for the device "JTS EXTENDIBLE DISTAL FEMORAL IMPLANT". The FDA issued a decision of Substantially Equivalent on January 22, 2014. 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
- January 22, 2014
- Date Received
- November 22, 2013
- Clearance Type
- Special
- 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