The following data is part of a premarket notification filed by Orthopedic Systems, Inc. with the FDA for Forearm Reduction Unit.
| Device ID | K823392 |
| 510k Number | K823392 |
| Device Name: | FOREARM REDUCTION UNIT |
| Classification | Apparatus, Traction, Non-powered |
| Applicant | ORTHOPEDIC SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HST |
| CFR Regulation Number | 888.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-12 |
| Decision Date | 1982-11-29 |