The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Charlotte Snap-off Screw, Models 45110001, 45110002, 45110003.
| Device ID | K043583 |
| 510k Number | K043583 |
| Device Name: | CHARLOTTE SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003 |
| Classification | Screw, Fixation, Bone |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Wesley L Reed |
| Correspondent | Wesley L Reed 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 | 2004-12-28 |
| Decision Date | 2005-01-26 |
| Summary: | summary |