The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Ortholoc(tm) Bone Screws.
| Device ID | K112772 |
| 510k Number | K112772 |
| Device Name: | ORTHOLOC(TM) BONE SCREWS |
| Classification | Screw, Fixation, Bone |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Kellen Hills |
| Correspondent | Kellen Hills WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-23 |
| Decision Date | 2011-10-07 |
| Summary: | summary |