The following data is part of a premarket notification filed by Stryker with the FDA for Stryker Sternalplate System.
| Device ID | K183172 |
| 510k Number | K183172 |
| Device Name: | Stryker SternalPlate System |
| Classification | Plate, Fixation, Bone |
| Applicant | Stryker 750 Trade Centre Way, Suite 200 Portage, MI 49002 |
| Contact | Hans Geiger |
| Correspondent | Hans Geiger Stryker 750 Trade Centre Way, Suite 200 Portage, MI 49002 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-16 |
| Decision Date | 2019-03-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327402049 | K183172 | 000 |
| 07613327384888 | K183172 | 000 |
| 07613327384864 | K183172 | 000 |
| 07613327384840 | K183172 | 000 |
| 07613327384833 | K183172 | 000 |
| 07613327384819 | K183172 | 000 |
| 07613327384796 | K183172 | 000 |
| 07613327384734 | K183172 | 000 |
| 07613327384727 | K183172 | 000 |
| 07613327384642 | K183172 | 000 |
| 07613327384604 | K183172 | 000 |
| 07613327384574 | K183172 | 000 |
| 07613327384543 | K183172 | 000 |
| 37613327384674 | K183172 | 000 |
| 07613327539806 | K183172 | 000 |
| 07613327590975 | K183172 | 000 |
| 07613327590968 | K183172 | 000 |
| 07613327384901 | K183172 | 000 |
| 07613327384925 | K183172 | 000 |
| 07613327384932 | K183172 | 000 |
| 07613327401998 | K183172 | 000 |
| 07613327401950 | K183172 | 000 |
| 07613327401943 | K183172 | 000 |
| 07613327401882 | K183172 | 000 |
| 07613327401752 | K183172 | 000 |
| 07613327401691 | K183172 | 000 |
| 07613327401684 | K183172 | 000 |
| 07613327385274 | K183172 | 000 |
| 07613327385229 | K183172 | 000 |
| 07613327385212 | K183172 | 000 |
| 07613327385182 | K183172 | 000 |
| 07613327385168 | K183172 | 000 |
| 07613327385076 | K183172 | 000 |
| 07613327384994 | K183172 | 000 |
| 07613327384970 | K183172 | 000 |
| 07613327384956 | K183172 | 000 |
| 07613327620771 | K183172 | 000 |