The following data is part of a premarket notification filed by Spine View, Inc. with the FDA for Enspire Debrider System.
| Device ID | K110992 |
| 510k Number | K110992 |
| Device Name: | ENSPIRE DEBRIDER SYSTEM |
| Classification | Arthroscope |
| Applicant | SPINE VIEW, INC. 48810 KATO ROAD SUITE 100E Fremont, CA 94538 |
| Contact | Mbithi Muthini |
| Correspondent | Mbithi Muthini SPINE VIEW, INC. 48810 KATO ROAD 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 | 2011-04-08 |
| Decision Date | 2011-10-21 |
| Summary: | summary |