The following data is part of a premarket notification filed by Life Spine with the FDA for Tarsa-link Wedge Fixation System.
| Device ID | K150368 |
| 510k Number | K150368 |
| Device Name: | Tarsa-Link Wedge Fixation System |
| Classification | Plate, Fixation, Bone |
| Applicant | Life Spine 13951 S. Quality Drive Huntley, IL 60142 |
| Contact | Randy Lewis |
| Correspondent | Randy Lewis Life Spine 13951 S. Quality Drive Huntley, IL 60142 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-12 |
| Decision Date | 2015-03-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190837063788 | K150368 | 000 |
| 00190837063634 | K150368 | 000 |
| 00190837063627 | K150368 | 000 |
| 00190837063610 | K150368 | 000 |
| 00190837063603 | K150368 | 000 |
| 00190837063597 | K150368 | 000 |
| 00190837063580 | K150368 | 000 |
| 00190837063573 | K150368 | 000 |
| 00190837063566 | K150368 | 000 |
| 00190837063559 | K150368 | 000 |
| 00190837063542 | K150368 | 000 |
| 00190837063535 | K150368 | 000 |
| 00190837063528 | K150368 | 000 |
| 00190837063641 | K150368 | 000 |
| 00190837063658 | K150368 | 000 |
| 00190837063771 | K150368 | 000 |
| 00190837063764 | K150368 | 000 |
| 00190837063757 | K150368 | 000 |
| 00190837063740 | K150368 | 000 |
| 00190837063733 | K150368 | 000 |
| 00190837063726 | K150368 | 000 |
| 00190837063719 | K150368 | 000 |
| 00190837063702 | K150368 | 000 |
| 00190837063696 | K150368 | 000 |
| 00190837063689 | K150368 | 000 |
| 00190837063672 | K150368 | 000 |
| 00190837063665 | K150368 | 000 |
| 00190837063511 | K150368 | 000 |