The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Charlotte 7.0 Multi-use Compression Screw And Washer.
| Device ID | K070525 |
| 510k Number | K070525 |
| Device Name: | CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER |
| Classification | Screw, Fixation, Bone |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Wesley L Reed |
| Correspondent | Wesley L Reed 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 | 2007-02-23 |
| Decision Date | 2007-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420109323 | K070525 | 000 |
| 00840420109194 | K070525 | 000 |
| 00840420109187 | K070525 | 000 |
| 00840420109170 | K070525 | 000 |
| 00840420109163 | K070525 | 000 |
| 00840420109132 | K070525 | 000 |
| 00840420109125 | K070525 | 000 |
| 00840420109118 | K070525 | 000 |
| 00840420109101 | K070525 | 000 |
| 00840420109095 | K070525 | 000 |
| 00840420109200 | K070525 | 000 |
| 00840420109217 | K070525 | 000 |
| 00840420109224 | K070525 | 000 |
| 00840420109316 | K070525 | 000 |
| 00840420109309 | K070525 | 000 |
| 00840420109293 | K070525 | 000 |
| 00840420109286 | K070525 | 000 |
| 00840420109279 | K070525 | 000 |
| 00840420109262 | K070525 | 000 |
| 00840420109255 | K070525 | 000 |
| 00840420109248 | K070525 | 000 |
| 00840420109231 | K070525 | 000 |
| 00840420109088 | K070525 | 000 |