The following data is part of a premarket notification filed by Life Spine, Inc with the FDA for The Hammertoe Correction System.
| Device ID | K153065 |
| 510k Number | K153065 |
| Device Name: | The Hammertoe Correction System |
| Classification | Screw, Fixation, Bone |
| Applicant | LIFE SPINE, INC 13951 S. Quality Drive Huntley, IL 60142 |
| Contact | Randy Lewis |
| Correspondent | Randy Lewis LIFE SPINE, INC 13951 S. Quality Drive Huntley, IL 60142 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-22 |
| Decision Date | 2016-08-01 |
| Summary: | summary |