The following data is part of a premarket notification filed by Stryker with the FDA for Stryker Medpor Titan 3d Orbital Floor Implant.
| Device ID | K142568 |
| 510k Number | K142568 |
| Device Name: | Stryker MEDPOR TITAN 3D Orbital Floor Implant |
| Classification | Plate, Bone |
| Applicant | Stryker 750 Trade Centre Way - Suite 200 Portage, MI 49009 |
| Contact | Julie Schoell |
| Correspondent | Julie Schoell Stryker 750 Trade Centre Way - Suite 200 Portage, MI 49009 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-12 |
| Decision Date | 2015-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327123296 | K142568 | 000 |
| 07613327123234 | K142568 | 000 |
| 07613327123227 | K142568 | 000 |
| 07613327123210 | K142568 | 000 |