The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Axsos Stryker Locked Plating System Line Extension Of Cable Plugs.
| Device ID | K092178 |
| 510k Number | K092178 |
| Device Name: | AXSOS STRYKER LOCKED PLATING SYSTEM LINE EXTENSION OF CABLE PLUGS |
| Classification | Plate, Fixation, Bone |
| Applicant | HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Melissa A Matarese |
| Correspondent | Melissa A Matarese HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-21 |
| Decision Date | 2009-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613154089505 | K092178 | 000 |
| 07613154089482 | K092178 | 000 |