The following data is part of a premarket notification filed by Stryker with the FDA for Stryker Universal Orbital Floor System.
| Device ID | K133461 |
| 510k Number | K133461 |
| Device Name: | STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM |
| Classification | Plate, Bone |
| Applicant | Stryker 750 TRADE CENTRE WAY STE 200 Portage, MI 49002 |
| Contact | Julie Schoell |
| Correspondent | Julie Schoell Stryker 750 TRADE CENTRE WAY STE 200 Portage, MI 49002 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-12 |
| Decision Date | 2014-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327503364 | K133461 | 000 |
| 07613327503357 | K133461 | 000 |
| 07613327503340 | K133461 | 000 |
| 07613327503333 | K133461 | 000 |