The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Mojave Expandable Interbody System.
| Device ID | K171097 |
| 510k Number | K171097 |
| Device Name: | MOJAVE Expandable Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | K2M, Inc. 600 Hope Parkway SE Leesburg, VA 20175 |
| Contact | Nancy Giezen |
| Correspondent | Nancy Giezen K2M 600 Hope Parkway SE Leesburg, VA 20175 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-13 |
| Decision Date | 2017-05-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857383265 | K171097 | 000 |
| 10888857378476 | K171097 | 000 |
| 10888857378469 | K171097 | 000 |
| 10888857370937 | K171097 | 000 |
| 10888857370920 | K171097 | 000 |
| 10888857370913 | K171097 | 000 |
| 10888857370876 | K171097 | 000 |
| 10888857370869 | K171097 | 000 |
| 10888857370852 | K171097 | 000 |
| 10888857370548 | K171097 | 000 |
| 10888857370531 | K171097 | 000 |
| 10888857370524 | K171097 | 000 |
| 10888857370487 | K171097 | 000 |
| 10888857370470 | K171097 | 000 |
| 10888857370463 | K171097 | 000 |
| 10888857370456 | K171097 | 000 |
| 10888857370449 | K171097 | 000 |
| 10888857378483 | K171097 | 000 |
| 10888857378520 | K171097 | 000 |
| 10888857383258 | K171097 | 000 |
| 10888857383241 | K171097 | 000 |
| 10888857383234 | K171097 | 000 |
| 10888857383227 | K171097 | 000 |
| 10888857383210 | K171097 | 000 |
| 10888857383203 | K171097 | 000 |
| 10888857383197 | K171097 | 000 |
| 10888857383180 | K171097 | 000 |
| 10888857383173 | K171097 | 000 |
| 10888857383166 | K171097 | 000 |
| 10888857383159 | K171097 | 000 |
| 10888857383142 | K171097 | 000 |
| 10888857383135 | K171097 | 000 |
| 10888857383128 | K171097 | 000 |
| 10888857378544 | K171097 | 000 |
| 10888857378537 | K171097 | 000 |
| 10888857370432 | K171097 | 000 |