The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Charlotte Lisfranc Bone Screw, Charlotte Lisfranc Plate.
| Device ID | K081374 |
| 510k Number | K081374 |
| Device Name: | CHARLOTTE LISFRANC BONE SCREW, CHARLOTTE LISFRANC PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Sarah Holtgrewe |
| Correspondent | Sarah Holtgrewe 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 | 2008-05-16 |
| Decision Date | 2008-09-09 |
| Summary: | summary |