The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Charlotte Claw 3.5.
| Device ID | K080295 |
| 510k Number | K080295 |
| Device Name: | CHARLOTTE CLAW 3.5 |
| Classification | Plate, Fixation, Bone |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Sarah Holtgrewe |
| Correspondent | Sarah Holtgrewe WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-04 |
| Decision Date | 2008-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420110077 | K080295 | 000 |
| 00840420109927 | K080295 | 000 |
| 00840420109910 | K080295 | 000 |
| 00840420109903 | K080295 | 000 |
| 00840420109897 | K080295 | 000 |
| 00840420109880 | K080295 | 000 |
| 00840420109873 | K080295 | 000 |
| 00840420109866 | K080295 | 000 |
| 00840420109859 | K080295 | 000 |
| 00840420109842 | K080295 | 000 |
| 00840420109804 | K080295 | 000 |
| 00840420109798 | K080295 | 000 |
| 00840420109781 | K080295 | 000 |
| 00840420109934 | K080295 | 000 |
| 00840420109941 | K080295 | 000 |
| 00840420110060 | K080295 | 000 |
| 00840420110053 | K080295 | 000 |
| 00840420110046 | K080295 | 000 |
| 00840420110039 | K080295 | 000 |
| 00840420110022 | K080295 | 000 |
| 00840420110015 | K080295 | 000 |
| 00840420110008 | K080295 | 000 |
| 00840420109996 | K080295 | 000 |
| 00840420109989 | K080295 | 000 |
| 00840420109972 | K080295 | 000 |
| 00840420109965 | K080295 | 000 |
| 00840420109958 | K080295 | 000 |
| 00840420140555 | K080295 | 000 |