The following data is part of a premarket notification filed by Interventional Spine, Inc. with the FDA for Opticage(r) Expandable Interbody Fusion Device.
| Device ID | K160464 |
| 510k Number | K160464 |
| Device Name: | Opticage(R) Expandable Interbody Fusion Device |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | INTERVENTIONAL SPINE, INC. 13700 ALTON PARKWAY SUITE 160 Irvine, CA 92618 |
| Contact | Jane Metcalf |
| Correspondent | Jane Metcalf INTERVENTIONAL SPINE, INC. 13700 ALTON PARKWAY SUITE 160 Irvine, CA 92618 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-19 |
| Decision Date | 2016-04-04 |
| Summary: | summary |