The following data is part of a premarket notification filed by Orthopedic Systems, Inc. with the FDA for Limited Motion Functional Knee Brace.
| Device ID | K831044 |
| 510k Number | K831044 |
| Device Name: | LIMITED MOTION FUNCTIONAL KNEE BRACE |
| Classification | Joint, Knee, External Brace |
| Applicant | ORTHOPEDIC SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | ITQ |
| CFR Regulation Number | 890.3475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-31 |
| Decision Date | 1983-06-24 |