The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Phalinx Hammertoe System.
| Device ID | K142585 |
| 510k Number | K142585 |
| Device Name: | PhaLinx Hammertoe System |
| Classification | Screw, Fixation, Bone |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 1023 CHERRY ROAD Memphis, TN 38117 |
| Contact | Val Myles |
| Correspondent | Val Myles WRIGHT MEDICAL TECHNOLOGY, INC. 1023 CHERRY ROAD Memphis, TN 38117 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-15 |
| Decision Date | 2014-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420166098 | K142585 | 000 |
| 00840420166067 | K142585 | 000 |
| 00840420166043 | K142585 | 000 |
| 00840420166036 | K142585 | 000 |
| 00840420166029 | K142585 | 000 |