The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Charlotte High-demand Compression Screw.
| Device ID | K043281 |
| 510k Number | K043281 |
| Device Name: | CHARLOTTE HIGH-DEMAND COMPRESSION SCREW |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-26 |
| Decision Date | 2005-01-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420109156 | K043281 | 000 |
| 00840420135032 | K043281 | 000 |
| 00840420135049 | K043281 | 000 |
| 00840420135056 | K043281 | 000 |
| 00840420135063 | K043281 | 000 |
| 00840420135070 | K043281 | 000 |
| 00840420135087 | K043281 | 000 |
| 00840420135094 | K043281 | 000 |
| 00840420135100 | K043281 | 000 |
| 00840420135117 | K043281 | 000 |
| 00840420135124 | K043281 | 000 |
| 00840420135131 | K043281 | 000 |
| 00840420135148 | K043281 | 000 |
| 00840420109149 | K043281 | 000 |
| 00840420135025 | K043281 | 000 |