The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Triathlon All-polyethylene Condylar Stabilizing (cs) Tibial Implants Triathlon All-polyethylene Posterior Stabilizing (p.
| Device ID | K123166 |
| 510k Number | K123166 |
| Device Name: | TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (P |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Audrey Witko |
| Correspondent | Audrey Witko HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-09 |
| Decision Date | 2013-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327259551 | K123166 | 000 |
| 07613327195569 | K123166 | 000 |
| 07613327195613 | K123166 | 000 |
| 07613327245080 | K123166 | 000 |
| 07613327248579 | K123166 | 000 |
| 07613327248654 | K123166 | 000 |
| 07613327248661 | K123166 | 000 |
| 07613327248746 | K123166 | 000 |
| 07613327248838 | K123166 | 000 |
| 07613327259407 | K123166 | 000 |
| 07613327259520 | K123166 | 000 |
| 07613327179606 | K123166 | 000 |