The following data is part of a premarket notification filed by Surgical Appliance Industries, Inc. with the FDA for Lumbo-sacral Flexion Orthosis.
| Device ID | K811494 |
| 510k Number | K811494 |
| Device Name: | LUMBO-SACRAL FLEXION ORTHOSIS |
| Classification | Orthosis, Lumbo-sacral |
| Applicant | SURGICAL APPLIANCE INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IPY |
| CFR Regulation Number | 890.3490 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-27 |
| Decision Date | 1981-06-16 |