510(k) K140898
K140898 is an FDA 510(k) premarket notification submitted by Stanmore Implants Worldwide , Ltd. for the device "PATIENT SPECIFIC DISTAL FEMORAL". The FDA issued a decision of Substantially Equivalent on Jan 20, 2015. 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
- Jan 20, 2015
- Date Received
- Apr 8, 2014
- 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
- 510(k)