The following data is part of a premarket notification filed by Stryker with the FDA for Stryker Universal Mesh.
| Device ID | K170725 |
| 510k Number | K170725 |
| Device Name: | Stryker Universal Mesh |
| Classification | Plate, Cranioplasty, Preformed, Alterable |
| Applicant | Stryker 750 Trade Centre Way-Suite 200 Portage, MI 49002 |
| Contact | Jonathan Schell |
| Correspondent | Jonathan Schell Stryker 750 Trade Centre Way-Suite 200 Portage, MI 49002 |
| Product Code | GWO |
| CFR Regulation Number | 882.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-09 |
| Decision Date | 2017-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327123388 | K170725 | 000 |
| 07613327123289 | K170725 | 000 |
| 07613327123241 | K170725 | 000 |
| 07613327123173 | K170725 | 000 |
| 07613327123142 | K170725 | 000 |