The following data is part of a premarket notification filed by Medical Design & Manufacturing Corp. with the FDA for Limb Orhtosis.
| Device ID | K810222 |
| 510k Number | K810222 |
| Device Name: | LIMB ORHTOSIS |
| Classification | Joint, Knee, External Brace |
| Applicant | MEDICAL DESIGN & MANUFACTURING CORP. 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 | 1981-01-27 |
| Decision Date | 1981-02-04 |