The following data is part of a premarket notification filed by Life Spine Inc. with the FDA for Dyna-link Elite Stand-alone Anterior Lumbar System.
| Device ID | K180215 |
| 510k Number | K180215 |
| Device Name: | DYNA-LINK ELITE Stand-Alone Anterior Lumbar System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| 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 | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-25 |
| Decision Date | 2018-09-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190837071240 | K180215 | 000 |
| 00190837104566 | K180215 | 000 |
| 00190837104573 | K180215 | 000 |
| 00190837104580 | K180215 | 000 |
| 00190837104603 | K180215 | 000 |
| 00190837104610 | K180215 | 000 |
| 00190837104627 | K180215 | 000 |
| 00190837034696 | K180215 | 000 |
| 00190837071233 | K180215 | 000 |
| 00190837104559 | K180215 | 000 |