The following data is part of a premarket notification filed by Clarus Medical, Llc. with the FDA for Spine Scope, Model 2180.
| Device ID | K011454 |
| 510k Number | K011454 |
| Device Name: | SPINE SCOPE, MODEL 2180 |
| Classification | Arthroscope |
| Applicant | CLARUS MEDICAL, LLC. 1000 BOONE AVE. NORTH Minneapolis, MN 55427 |
| Contact | Tom Barthel |
| Correspondent | Tom Barthel CLARUS MEDICAL, LLC. 1000 BOONE AVE. NORTH Minneapolis, MN 55427 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-11 |
| Decision Date | 2001-12-13 |