The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Pro-toe Vo Hammertow Implant System.
| Device ID | K101165 |
| 510k Number | K101165 |
| Device Name: | PRO-TOE VO HAMMERTOW IMPLANT SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Kelsey Lee |
| Correspondent | Kelsey Lee 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 | 2010-04-26 |
| Decision Date | 2010-07-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420151759 | K101165 | 000 |
| 00840420151742 | K101165 | 000 |
| 00840420151735 | K101165 | 000 |
| 00840420151728 | K101165 | 000 |