The following data is part of a premarket notification filed by Life Spine with the FDA for Pro-link Wedge System.
| Device ID | K141905 |
| 510k Number | K141905 |
| Device Name: | PRO-LINK WEDGE SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | LIFE SPINE 2401 W. HASSELL RD. SUITE 1535 Hoffman Estates, IL 60169 |
| Contact | Randy Lewis |
| Correspondent | Randy Lewis LIFE SPINE 2401 W. HASSELL RD. SUITE 1535 Hoffman Estates, IL 60169 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-15 |
| Decision Date | 2014-09-26 |
| Summary: | summary |