The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Sahara Stabilization System.
| Device ID | K190179 |
| 510k Number | K190179 |
| Device Name: | SAHARA Stabilization System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | K2M, Inc. 600 Hope Parkway SE Leesburg, VA 20175 |
| Contact | Oonagh Lahiff |
| Correspondent | Renee Norby Stryker 2 Pearl Court Allendale, NJ 07401 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-01 |
| Decision Date | 2019-10-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857462762 | K190179 | 000 |
| 10888857462649 | K190179 | 000 |
| 10888857462632 | K190179 | 000 |
| 10888857462625 | K190179 | 000 |
| 10888857462618 | K190179 | 000 |
| 10888857462212 | K190179 | 000 |
| 10888857462205 | K190179 | 000 |
| 10888857462199 | K190179 | 000 |
| 10888857462182 | K190179 | 000 |
| 10888857462656 | K190179 | 000 |
| 10888857462663 | K190179 | 000 |
| 10888857462670 | K190179 | 000 |
| 10888857462755 | K190179 | 000 |
| 10888857462748 | K190179 | 000 |
| 10888857462731 | K190179 | 000 |
| 10888857462724 | K190179 | 000 |
| 10888857462717 | K190179 | 000 |
| 10888857462700 | K190179 | 000 |
| 10888857462694 | K190179 | 000 |
| 10888857462687 | K190179 | 000 |
| 10888857494442 | K190179 | 000 |