The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Stryker Sonicpin System.
| Device ID | K091955 |
| 510k Number | K091955 |
| Device Name: | STRYKER SONICPIN SYSTEM |
| Classification | Pin, Fixation, Smooth |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Avital Merl-margulies |
| Correspondent | Avital Merl-margulies HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-01 |
| Decision Date | 2010-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327051292 | K091955 | 000 |
| 07613252495130 | K091955 | 000 |
| 07613252495109 | K091955 | 000 |
| 07613252495093 | K091955 | 000 |
| 07613252495086 | K091955 | 000 |
| 07613252495079 | K091955 | 000 |