The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Small Bone Wedge.
| Device ID | K070592 |
| 510k Number | K070592 |
| Device Name: | SMALL BONE WEDGE |
| Classification | Plate, 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-02 |
| Decision Date | 2007-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420143266 | K070592 | 000 |
| 00840420135698 | K070592 | 000 |
| 00840420135704 | K070592 | 000 |
| 00840420143181 | K070592 | 000 |
| 00840420143198 | K070592 | 000 |
| 00840420143204 | K070592 | 000 |
| 00840420143211 | K070592 | 000 |
| 00840420143228 | K070592 | 000 |
| 00840420143235 | K070592 | 000 |
| 00840420143242 | K070592 | 000 |
| 00840420143259 | K070592 | 000 |
| 00840420135681 | K070592 | 000 |