The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Ortholoc 2.0/2.4 Plate System.
| Device ID | K090692 |
| 510k Number | K090692 |
| Device Name: | ORTHOLOC 2.0/2.4 PLATE SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Fred W Bowman |
| Correspondent | Fred W Bowman WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-16 |
| Decision Date | 2009-05-08 |
| Summary: | summary |