The following data is part of a premarket notification filed by Stanmore Implants Worldwide Ltd. with the FDA for Jts Extendeable Implant.
Device ID | K092138 |
510k Number | K092138 |
Device Name: | JTS EXTENDEABLE 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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-07-15 |
Decision Date | 2011-03-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05060296233167 | K092138 | 000 |
05060296236168 | K092138 | 000 |
05060296236137 | K092138 | 000 |
05060296233822 | K092138 | 000 |
05060296233815 | K092138 | 000 |
05060296233808 | K092138 | 000 |
05060296233617 | K092138 | 000 |
05060296233600 | K092138 | 000 |
05060296233587 | K092138 | 000 |
05060296233570 | K092138 | 000 |
05060296236397 | K092138 | 000 |
05060296236182 | K092138 | 000 |
05060296236007 | K092138 | 000 |
05060296233877 | K092138 | 000 |
05060296233853 | K092138 | 000 |
05060296233839 | K092138 | 000 |
05060296233754 | K092138 | 000 |
05060296233693 | K092138 | 000 |
05060296236380 | K092138 | 000 |
05060296236236 | K092138 | 000 |
05060296236243 | K092138 | 000 |
05060296233150 | K092138 | 000 |
05060296233136 | K092138 | 000 |
05060296232825 | K092138 | 000 |
05060296232818 | K092138 | 000 |
05060296232023 | K092138 | 000 |
05060296232016 | K092138 | 000 |
05060296232009 | K092138 | 000 |
05060296231996 | K092138 | 000 |
05060296231989 | K092138 | 000 |
05060296236106 | K092138 | 000 |
05060296236090 | K092138 | 000 |
05060296236083 | K092138 | 000 |
05060296236076 | K092138 | 000 |
05060296236069 | K092138 | 000 |
05060296236052 | K092138 | 000 |
05060296232832 | K092138 | 000 |
05060296236250 | K092138 | 000 |
05060296233631 | K092138 | 000 |