The following data is part of a premarket notification filed by Stanmore Implants Worldwide Ltd. with the FDA for Jts Extendible Distal Femoral Implant.
Device ID | K133152 |
510k Number | K133152 |
Device Name: | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT |
Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
Applicant | STANMORE IMPLANTS WORLDWIDE LTD. 555 THIRTEENTH ST, NW Washington, DC 20004 |
Contact | Gerard J Prud'homme |
Correspondent | Gerard J Prud'homme STANMORE IMPLANTS WORLDWIDE LTD. 555 THIRTEENTH ST, NW Washington, DC 20004 |
Product Code | KRO |
CFR Regulation Number | 888.3510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-11-22 |
Decision Date | 2014-01-22 |
Summary: | summary |