The following data is part of a premarket notification filed by Spine View, Inc. with the FDA for Enspire Debrider System.
| Device ID | K090278 |
| 510k Number | K090278 |
| Device Name: | ENSPIRE DEBRIDER SYSTEM |
| Classification | Arthroscope |
| Applicant | SPINE VIEW, INC. 48541 WARM SPRINGS BLVD. SUITE 507 Fremont, CA 94539 |
| Contact | Sandra Sundell |
| Correspondent | Sandra Sundell SPINE VIEW, INC. 48541 WARM SPRINGS BLVD. SUITE 507 Fremont, CA 94539 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-04 |
| Decision Date | 2009-04-15 |
| Summary: | summary |