The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Ortholoc 3dsi Locking Screws.
| Device ID | K113339 |
| 510k Number | K113339 |
| Device Name: | ORTHOLOC 3DSI LOCKING SCREWS |
| Classification | Plate, Fixation, Bone |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Peggy S Rivers |
| Correspondent | Peggy S Rivers WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-14 |
| Decision Date | 2011-12-12 |
| Summary: | summary |