The following data is part of a premarket notification filed by Ortho Select Implant Technology Gesellschaft with the FDA for Ortho Select Bone Plates And Screw System.
| Device ID | K091493 |
| 510k Number | K091493 |
| Device Name: | ORTHO SELECT BONE PLATES AND SCREW SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | ORTHO SELECT IMPLANT TECHNOLOGY GESELLSCHAFT AMSTEL 320-1 Amsterdam, NL 1017ap |
| Contact | Angelika Scherp |
| Correspondent | Angelika Scherp ORTHO SELECT IMPLANT TECHNOLOGY GESELLSCHAFT AMSTEL 320-1 Amsterdam, NL 1017ap |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-20 |
| Decision Date | 2010-02-05 |
| Summary: | summary |