The following data is part of a premarket notification filed by Orthopedic Systems, Inc. with the FDA for Free Flex Heel Height Adjustor.
| Device ID | K823396 |
| 510k Number | K823396 |
| Device Name: | FREE FLEX HEEL HEIGHT ADJUSTOR |
| Classification | Component, External, Limb, Ankle/foot |
| Applicant | ORTHOPEDIC SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ISH |
| CFR Regulation Number | 890.3420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-12 |
| Decision Date | 1982-11-29 |