The following data is part of a premarket notification filed by Stryker with the FDA for Universal Neuro 3 System.
| Device ID | K131775 |
| 510k Number | K131775 |
| Device Name: | UNIVERSAL NEURO 3 SYSTEM |
| Classification | Plate, Cranioplasty, Preformed, Alterable |
| Applicant | Stryker 750 TRADE CENTRE WAY STE 200 Portage, MI 49002 |
| Contact | Manish Patel |
| Correspondent | Manish Patel Stryker 750 TRADE CENTRE WAY STE 200 Portage, MI 49002 |
| Product Code | GWO |
| Subsequent Product Code | GXR |
| Subsequent Product Code | HBW |
| CFR Regulation Number | 882.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-17 |
| Decision Date | 2013-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613252524557 | K131775 | 000 |
| 07613252524496 | K131775 | 000 |
| 07613252524519 | K131775 | 000 |
| 07613252524526 | K131775 | 000 |
| 07613252524540 | K131775 | 000 |
| 07613252524564 | K131775 | 000 |
| 07613252524465 | K131775 | 000 |
| 07613252524502 | K131775 | 000 |
| 07613252524533 | K131775 | 000 |
| 07613252524458 | K131775 | 000 |