The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Charlotte (tm) Snap-off Screw.
| Device ID | K133713 |
| 510k Number | K133713 |
| Device Name: | CHARLOTTE (TM) SNAP-OFF SCREW |
| Classification | Screw, 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-05 |
| Decision Date | 2014-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420109439 | K133713 | 000 |
| 00840420130259 | K133713 | 000 |
| 00840420130266 | K133713 | 000 |
| 00840420130273 | K133713 | 000 |
| 00840420130280 | K133713 | 000 |
| 00840420130297 | K133713 | 000 |
| 00840420109330 | K133713 | 000 |
| 00840420109347 | K133713 | 000 |
| 00840420109354 | K133713 | 000 |
| 00840420109361 | K133713 | 000 |
| 00840420109378 | K133713 | 000 |
| 00840420109385 | K133713 | 000 |
| 00840420109392 | K133713 | 000 |
| 00840420109408 | K133713 | 000 |
| 00840420109415 | K133713 | 000 |
| 00840420109422 | K133713 | 000 |
| 00840420130242 | K133713 | 000 |