The following data is part of a premarket notification filed by Life Spine Inc. with the FDA for Cannulated Screw Internal Fixation System.
| Device ID | K173286 |
| 510k Number | K173286 |
| Device Name: | Cannulated Screw Internal Fixation 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 | 2017-10-16 |
| Decision Date | 2017-12-14 |
| Summary: | summary |