The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Stryker Orthopaedics Rfid Instrumentation.
| Device ID | K053348 |
| 510k Number | K053348 |
| Device Name: | STRYKER ORTHOPAEDICS RFID INSTRUMENTATION |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Vivian Kelly |
| Correspondent | Vivian Kelly HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-02 |
| Decision Date | 2006-08-04 |
| Summary: | summary |