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 |