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 |
|---|---|---|
| B278IMBCEXSM0 | K092138 | 000 |
| B278SMTBC00G0 | K092138 | 000 |
| B278SMTBC01G0 | K092138 | 000 |
| B278SMTBC02G0 | K092138 | 000 |
| B278TCKAXLEXSM0 | K092138 | 000 |
| B278TCKAXLSTD0 | K092138 | 000 |
| B278IMBCNUT0 | K092138 | 000 |
| B278IMBCSTD0 | K092138 | 000 |
| B278IMCIRPR0 | K092138 | 000 |
| B278IMGENIMP0 | K092138 | 000 |
| B278IMHAM0 | K092138 | 000 |
| B278IMOSTME150 | K092138 | 000 |
| B278IMPBIMPSTD0 | K092138 | 000 |
| B278IMTIBJIGPRG0 | K092138 | 000 |
| B278IMTIBJIGROD0 | K092138 | 000 |
| B278IMTIBJIGRST0 | K092138 | 000 |
| B278JTSDFLXSM0 | K092138 | 000 |
| B278JTSDFRSTD0 | K092138 | 000 |
| B278SMCIC010 | K092138 | 000 |
| B278SMCAP010 | K092138 | 000 |
| B278JTSDFLSTD0 | K092138 | 000 |
| B278IMARDRL0 | K092138 | 000 |
| B278IMAXCP0 | K092138 | 000 |
| B278IMBCSM0 | K092138 | 000 |
| B278IMPBIMPEXSM0 | K092138 | 000 |
| B278IMPBIMPSM0 | K092138 | 000 |
| B278JTSDFLSM0 | K092138 | 000 |
| B278JTSDFRSM0 | K092138 | 000 |
| B278JTSDFRXSM0 | K092138 | 000 |
| B278JTSDRIVEUNIT0 | K092138 | 000 |
| B278PIN0 | K092138 | 000 |
| B278PINS0 | K092138 | 000 |
| B278SMBPR000 | K092138 | 000 |
| B278SMBPR010 | K092138 | 000 |
| B278SMBSH000 | K092138 | 000 |
| B278SMBSH010 | K092138 | 000 |
| B278SMBSH020 | K092138 | 000 |
| B278SMBPR020 | K092138 | 000 |
| 05060296233631 | K092138 | 000 |
| 05060296233693 | K092138 | 000 |
| 05060296236250 | K092138 | 000 |
| 05060296232832 | K092138 | 000 |
| 05060296236052 | K092138 | 000 |
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| 05060296233167 | K092138 | 000 |