The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Charlotte Claw Plate System.
| Device ID | K133715 |
| 510k Number | K133715 |
| Device Name: | CHARLOTTE CLAW PLATE SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Leslie Fitch |
| Correspondent | Leslie Fitch 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 | 2013-12-05 |
| Decision Date | 2014-02-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420109835 | K133715 | 000 |
| 00840420135292 | K133715 | 000 |
| 00840420135285 | K133715 | 000 |
| 00840420135278 | K133715 | 000 |
| 00840420135261 | K133715 | 000 |
| 00840420135254 | K133715 | 000 |
| 00840420135247 | K133715 | 000 |
| 00840420135230 | K133715 | 000 |
| 00840420135223 | K133715 | 000 |
| 00840420135216 | K133715 | 000 |
| 00840420135209 | K133715 | 000 |
| 00840420135193 | K133715 | 000 |
| 00840420135186 | K133715 | 000 |
| 00840420109651 | K133715 | 000 |
| 00840420109668 | K133715 | 000 |
| 00840420109675 | K133715 | 000 |
| 00840420109828 | K133715 | 000 |
| 00840420109811 | K133715 | 000 |
| 00840420109774 | K133715 | 000 |
| 00840420109767 | K133715 | 000 |
| 00840420109750 | K133715 | 000 |
| 00840420109743 | K133715 | 000 |
| 00840420109736 | K133715 | 000 |
| 00840420109729 | K133715 | 000 |
| 00840420109712 | K133715 | 000 |
| 00840420109705 | K133715 | 000 |
| 00840420109699 | K133715 | 000 |
| 00840420109682 | K133715 | 000 |
| 00840420135179 | K133715 | 000 |