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 |