The following data is part of a premarket notification filed by Howmedica Osteonics Corp Dba Stryker Orthopaedics with the FDA for Axsos Locked Plating 4.0mm Locking Inserts.
| Device ID | K110176 |
| 510k Number | K110176 |
| Device Name: | AXSOS LOCKED PLATING 4.0MM LOCKING INSERTS |
| Classification | Plate, Fixation, Bone |
| Applicant | HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Anthony Dennis |
| Correspondent | Anthony Dennis HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS 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 | 2011-01-21 |
| Decision Date | 2011-02-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613154089444 | K110176 | 000 |