The following data is part of a premarket notification filed by Stryker with the FDA for Mp Lefort I Plates.
| Device ID | K171364 |
| 510k Number | K171364 |
| Device Name: | MP LeFort I Plates |
| Classification | Plate, Bone |
| Applicant | Stryker 750 Trade Centre Way Suite 200 Portage, MI 49002 |
| Contact | Gregory Gohl |
| Correspondent | Gregory Gohl Stryker 750 Trade Centre Way Suite 200 Portage, MI 49002 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-09 |
| Decision Date | 2017-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327359848 | K171364 | 000 |
| 07613327359701 | K171364 | 000 |
| 07613327359718 | K171364 | 000 |
| 07613327359725 | K171364 | 000 |
| 07613327359763 | K171364 | 000 |
| 07613327359787 | K171364 | 000 |
| 07613327359794 | K171364 | 000 |
| 07613327359800 | K171364 | 000 |
| 07613327359817 | K171364 | 000 |
| 07613327359671 | K171364 | 000 |