The following data is part of a premarket notification filed by Stryker with the FDA for Stryker Universal Neuro Iii System Axs Screw.
| Device ID | K171152 |
| 510k Number | K171152 |
| Device Name: | Stryker Universal Neuro III System AXS Screw |
| Classification | Fastener, Plate, Cranioplasty |
| 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 | HBW |
| CFR Regulation Number | 882.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-20 |
| Decision Date | 2017-05-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327357240 | K171152 | 000 |
| 07613327282320 | K171152 | 000 |
| 07613327282313 | K171152 | 000 |
| 37613327357258 | K171152 | 000 |
| 37613327357227 | K171152 | 000 |
| 37613327357203 | K171152 | 000 |
| 37613327357197 | K171152 | 000 |
| 37613327357166 | K171152 | 000 |
| 37613327357159 | K171152 | 000 |
| 07613327282337 | K171152 | 000 |
| 07613327282344 | K171152 | 000 |
| 07613327357233 | K171152 | 000 |
| 07613327357219 | K171152 | 000 |
| 07613327357189 | K171152 | 000 |
| 07613327357172 | K171152 | 000 |
| 07613327357141 | K171152 | 000 |
| 07613327357134 | K171152 | 000 |
| 07613327282382 | K171152 | 000 |
| 07613327282375 | K171152 | 000 |
| 37613327357128 | K171152 | 000 |