The following data is part of a premarket notification filed by Life Spine Inc. with the FDA for Tarsa-link Stand-alone Wedge Fixation System.
| Device ID | K161037 |
| 510k Number | K161037 |
| Device Name: | Tarsa-Link Stand-Alone Wedge Fixation System |
| Classification | Plate, 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-13 |
| Decision Date | 2016-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190837066505 | K161037 | 000 |
| 00190837022679 | K161037 | 000 |
| 00190837022662 | K161037 | 000 |
| 00190837022655 | K161037 | 000 |
| 00190837022648 | K161037 | 000 |
| 00190837022631 | K161037 | 000 |
| 00190837022624 | K161037 | 000 |
| 00190837022617 | K161037 | 000 |
| 00190837022600 | K161037 | 000 |
| 00190837022594 | K161037 | 000 |
| 00190837022587 | K161037 | 000 |
| 00190837022570 | K161037 | 000 |
| 00190837022563 | K161037 | 000 |
| 00190837022556 | K161037 | 000 |
| 00190837022549 | K161037 | 000 |
| 00190837022532 | K161037 | 000 |
| 00190837022525 | K161037 | 000 |
| 00190837022686 | K161037 | 000 |
| 00190837022693 | K161037 | 000 |
| 00190837066499 | K161037 | 000 |
| 00190837066482 | K161037 | 000 |
| 00190837066475 | K161037 | 000 |
| 00190837066468 | K161037 | 000 |
| 00190837066451 | K161037 | 000 |
| 00190837066444 | K161037 | 000 |
| 00190837066437 | K161037 | 000 |
| 00190837066420 | K161037 | 000 |
| 00190837066413 | K161037 | 000 |
| 00190837066406 | K161037 | 000 |
| 00190837066390 | K161037 | 000 |
| 00190837066383 | K161037 | 000 |
| 00190837066376 | K161037 | 000 |
| 00190837066369 | K161037 | 000 |
| 00190837066352 | K161037 | 000 |
| 00190837066345 | K161037 | 000 |
| 00190837022518 | K161037 | 000 |