The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Pro-toe Hammertoe Fixation System.
| Device ID | K140148 |
| 510k Number | K140148 |
| Device Name: | PRO-TOE HAMMERTOE FIXATION SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Val Myles |
| Correspondent | Val Myles WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-22 |
| Decision Date | 2014-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420123190 | K140148 | 000 |
| 00840420160089 | K140148 | 000 |
| 00840420160102 | K140148 | 000 |
| 00840420160119 | K140148 | 000 |
| 00840420160126 | K140148 | 000 |
| 00840420160133 | K140148 | 000 |
| 00840420160294 | K140148 | 000 |
| 00840420160447 | K140148 | 000 |
| 00840420123121 | K140148 | 000 |
| 00840420123138 | K140148 | 000 |
| 00840420123145 | K140148 | 000 |
| 00840420123152 | K140148 | 000 |
| 00840420123169 | K140148 | 000 |
| 00840420123176 | K140148 | 000 |
| 00840420123183 | K140148 | 000 |
| 00840420159953 | K140148 | 000 |