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 |