The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Pro-toe(tm) Vo Hamertoe Implant System-line Sddition.
| Device ID | K120645 |
| 510k Number | K120645 |
| Device Name: | PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION |
| Classification | Screw, Fixation, Bone |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Ryan Bormann |
| Correspondent | Ryan Bormann 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 | 2012-03-02 |
| Decision Date | 2012-04-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420123114 | K120645 | 000 |
| 00840420123039 | K120645 | 000 |
| 00840420123046 | K120645 | 000 |
| 00840420123053 | K120645 | 000 |
| 00840420123060 | K120645 | 000 |
| 00840420123077 | K120645 | 000 |
| 00840420123084 | K120645 | 000 |
| 00840420123091 | K120645 | 000 |
| 00840420123107 | K120645 | 000 |
| 00840420123022 | K120645 | 000 |