The following data is part of a premarket notification filed by Stryker with the FDA for Stryker Quikflap Sterile Procedure Pack.
| Device ID | K120352 |
| 510k Number | K120352 |
| Device Name: | STRYKER QUIKFLAP STERILE PROCEDURE PACK |
| Classification | Plate, Cranioplasty, Preformed, Alterable |
| Applicant | Stryker 750 TRADE CENTER WAY STE 200 Portage, MI 49002 |
| Contact | Jamshed Badarpura |
| Correspondent | Jamshed Badarpura Stryker 750 TRADE CENTER WAY STE 200 Portage, MI 49002 |
| Product Code | GWO |
| CFR Regulation Number | 882.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-06 |
| Decision Date | 2012-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613252288237 | K120352 | 000 |
| 07613252288220 | K120352 | 000 |
| 07613252288213 | K120352 | 000 |
| 07613252288206 | K120352 | 000 |
| 07613252288190 | K120352 | 000 |
| 07613252288183 | K120352 | 000 |