The following data is part of a premarket notification filed by Spine View, Inc. with the FDA for Flexlite Camera.
| Device ID | K122134 |
| 510k Number | K122134 |
| Device Name: | FLEXLITE CAMERA |
| Classification | Arthroscope |
| Applicant | SPINE VIEW, INC. 48810 Kato Rd. Suite 100E Fremont, CA 94538 |
| Contact | Mbithi Muthini |
| Correspondent | Mbithi Muthini SPINE VIEW, INC. 48810 Kato Rd. Suite 100E Fremont, CA 94538 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-18 |
| Decision Date | 2012-12-27 |
| Summary: | summary |