The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Sterile Phalinx Hammertoe System.
| Device ID | K212996 |
| 510k Number | K212996 |
| Device Name: | Sterile PHALINX Hammertoe System |
| Classification | Screw, Fixation, Bone |
| Applicant | Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 37117 |
| Contact | Michael Mullins |
| Correspondent | Michael Mullins Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 37117 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-20 |
| Decision Date | 2021-11-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889797102209 | K212996 | 000 |
| 00889797102193 | K212996 | 000 |
| 00889797102186 | K212996 | 000 |
| 00889797102179 | K212996 | 000 |
| 00889797102162 | K212996 | 000 |
| 00889797102155 | K212996 | 000 |
| 00889797102148 | K212996 | 000 |
| 00889797102131 | K212996 | 000 |