The following data is part of a premarket notification filed by Life Spine, Inc. with the FDA for 2-piece Hammertoe Correction System.
| Device ID | K162685 |
| 510k Number | K162685 |
| Device Name: | 2-Piece 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 | 2016-09-26 |
| Decision Date | 2017-06-09 |
| Summary: | summary |