The following data is part of a premarket notification filed by Spine View, Inc. with the FDA for Spinevu Endoscopic Spine System (sess).
| Device ID | K121548 |
| 510k Number | K121548 |
| Device Name: | SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS) |
| Classification | Arthroscope |
| Applicant | SPINE VIEW, INC. 48810 Kato Rd. Suite 100E Fremont, CA 94538 |
| Contact | Diana Degregorio |
| Correspondent | Diana Degregorio SPINE VIEW, INC. 48810 Kato Rd. Suite 100E Fremont, CA 94538 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-25 |
| Decision Date | 2012-08-16 |
| Summary: | summary |