The following data is part of a premarket notification filed by Stryker with the FDA for Stryker Universal Neuro Iii System: Un Iii Axs Screw, Un Iii Axs Screwdriver Blade.
| Device ID | K151387 |
| 510k Number | K151387 |
| Device Name: | Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade |
| 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 | 2015-05-26 |
| Decision Date | 2015-06-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327090772 | K151387 | 000 |
| 07613327090673 | K151387 | 000 |
| 07613327090680 | K151387 | 000 |
| 07613327090697 | K151387 | 000 |
| 07613327090703 | K151387 | 000 |
| 07613327090710 | K151387 | 000 |
| 07613327090727 | K151387 | 000 |
| 07613327090734 | K151387 | 000 |
| 07613327090741 | K151387 | 000 |
| 07613327090758 | K151387 | 000 |
| 07613327090765 | K151387 | 000 |
| 07613327090604 | K151387 | 000 |