The following data is part of a premarket notification filed by Stryker with the FDA for Stryker Customized Mandible Recon Plate Kit.
| Device ID | K132519 |
| 510k Number | K132519 |
| Device Name: | STRYKER CUSTOMIZED MANDIBLE RECON PLATE KIT |
| Classification | Plate, Bone |
| Applicant | Stryker 750 TRADE CENTRE WAY STE 200 Portage, MI 49002 |
| Contact | Rob Yamashita |
| Correspondent | Rob Yamashita Stryker 750 TRADE CENTRE WAY STE 200 Portage, MI 49002 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-12 |
| Decision Date | 2013-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613252599678 | K132519 | 000 |
| 07613252599661 | K132519 | 000 |
| 07613252599654 | K132519 | 000 |
| 07613252599647 | K132519 | 000 |
| 07613252578239 | K132519 | 000 |
| 07613252578222 | K132519 | 000 |
| 07613252578215 | K132519 | 000 |
| 07613252578208 | K132519 | 000 |