The following data is part of a premarket notification filed by Orthopedic Systems, Inc. with the FDA for Comprehensive Spine Motion Analyzer.
| Device ID | K894283 |
| 510k Number | K894283 |
| Device Name: | COMPREHENSIVE SPINE MOTION ANALYZER |
| Classification | Goniometer, Ac-powered |
| Applicant | ORTHOPEDIC SYSTEMS, INC. 1897 NATIONAL AVE. Hayward, CA 94545 |
| Contact | Robert Moore |
| Correspondent | Robert Moore ORTHOPEDIC SYSTEMS, INC. 1897 NATIONAL AVE. Hayward, CA 94545 |
| Product Code | KQX |
| CFR Regulation Number | 888.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-23 |
| Decision Date | 1990-01-19 |