The following data is part of a premarket notification filed by Stryker with the FDA for Stryker Universal Mesh.
| Device ID | K161821 |
| 510k Number | K161821 |
| 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 | 2016-07-01 |
| Decision Date | 2016-12-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327459500 | K161821 | 000 |
| 07613327123043 | K161821 | 000 |
| 07613327123036 | K161821 | 000 |
| 07613327123012 | K161821 | 000 |
| 07613327123005 | K161821 | 000 |
| 07613327122985 | K161821 | 000 |
| 07613327122954 | K161821 | 000 |
| 07613327122947 | K161821 | 000 |
| 07613327122930 | K161821 | 000 |
| 07613327122923 | K161821 | 000 |
| 07613327122916 | K161821 | 000 |
| 07613327122909 | K161821 | 000 |
| 07613327122886 | K161821 | 000 |
| 07613327123050 | K161821 | 000 |
| 07613327123074 | K161821 | 000 |
| 07613327123081 | K161821 | 000 |
| 07613327123333 | K161821 | 000 |
| 07613327123326 | K161821 | 000 |
| 07613327123258 | K161821 | 000 |
| 07613327123203 | K161821 | 000 |
| 07613327123197 | K161821 | 000 |
| 07613327123180 | K161821 | 000 |
| 07613327123166 | K161821 | 000 |
| 07613327123159 | K161821 | 000 |
| 07613327123128 | K161821 | 000 |
| 07613327123111 | K161821 | 000 |
| 07613327123104 | K161821 | 000 |
| 07613327123098 | K161821 | 000 |
| 07613327122879 | K161821 | 000 |