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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060296236175 | K133152 | 000 |
| 05060296233747 | K133152 | 000 |
| 05060296233730 | K133152 | 000 |
| 05060296233723 | K133152 | 000 |
| 05060296233716 | K133152 | 000 |
| 05060296235970 | K133152 | 000 |
| 05060296232849 | K133152 | 000 |
| 05060296232061 | K133152 | 000 |
| 05060296232054 | K133152 | 000 |
| 05060296232047 | K133152 | 000 |
| 05060296232030 | K133152 | 000 |
| 05060296230340 | K133152 | 000 |
| 05060296230333 | K133152 | 000 |
| 05060296230326 | K133152 | 000 |
| 05060296230319 | K133152 | 000 |
| 05060296230302 | K133152 | 000 |
| 05060296230296 | K133152 | 000 |
| 05060296230289 | K133152 | 000 |
| 05060296236335 | K133152 | 000 |
| 05060296236342 | K133152 | 000 |
| 05060296234362 | K133152 | 000 |
| 05060296236151 | K133152 | 000 |
| 05060296233860 | K133152 | 000 |
| 05060296233846 | K133152 | 000 |
| 05060296233778 | K133152 | 000 |
| 05060296233761 | K133152 | 000 |
| 05060296233709 | K133152 | 000 |
| 05060296236229 | K133152 | 000 |
| 05060296236212 | K133152 | 000 |
| 05060296236205 | K133152 | 000 |
| 05060296236199 | K133152 | 000 |
| 05060296234430 | K133152 | 000 |
| 05060296234423 | K133152 | 000 |
| 05060296234416 | K133152 | 000 |
| 05060296234409 | K133152 | 000 |
| 05060296234393 | K133152 | 000 |
| 05060296234386 | K133152 | 000 |
| 05060296234379 | K133152 | 000 |
| 05060296230272 | K133152 | 000 |