The following data is part of a premarket notification filed by Orthopedic Systems, Inc. with the FDA for Orthopedic Lower Extremity Suspension.
| Device ID | K801436 |
| 510k Number | K801436 |
| Device Name: | ORTHOPEDIC LOWER EXTREMITY SUSPENSION |
| Classification | Splint, Extremity, Noninflatable, External, Sterile |
| Applicant | ORTHOPEDIC SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FYH |
| CFR Regulation Number | 878.3910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-06-19 |
| Decision Date | 1980-06-26 |