The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Charlotte Carolina Jones Fracture System Screw.
| Device ID | K140952 |
| 510k Number | K140952 |
| Device Name: | CHARLOTTE CAROLINA JONES FRACTURE SYSTEM SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 1023 CHERRY ROAD Memphis, TN 38117 |
| Contact | Leslie Fitch |
| Correspondent | Leslie Fitch WRIGHT MEDICAL TECHNOLOGY, INC. 1023 CHERRY ROAD Memphis, TN 38117 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-14 |
| Decision Date | 2014-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420109644 | K140952 | 000 |
| 00840420109514 | K140952 | 000 |
| 00840420109507 | K140952 | 000 |
| 00840420109491 | K140952 | 000 |
| 00840420109484 | K140952 | 000 |
| 00840420109477 | K140952 | 000 |
| 00840420109460 | K140952 | 000 |
| 00840420109453 | K140952 | 000 |
| 00840420109446 | K140952 | 000 |
| 00840420185921 | K140952 | 000 |
| 00840420109521 | K140952 | 000 |
| 00840420109538 | K140952 | 000 |
| 00840420109545 | K140952 | 000 |
| 00840420109637 | K140952 | 000 |
| 00840420109620 | K140952 | 000 |
| 00840420109613 | K140952 | 000 |
| 00840420109606 | K140952 | 000 |
| 00840420109590 | K140952 | 000 |
| 00840420109583 | K140952 | 000 |
| 00840420109576 | K140952 | 000 |
| 00840420109569 | K140952 | 000 |
| 00840420109552 | K140952 | 000 |
| 00840420135575 | K140952 | 000 |