The following data is part of a premarket notification filed by Medishield, Inc. with the FDA for Ankle (freeman-swanson).
| Device ID | K761020 |
| 510k Number | K761020 |
| Device Name: | ANKLE (FREEMAN-SWANSON) |
| Classification | Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer |
| Applicant | MEDISHIELD, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HSN |
| CFR Regulation Number | 888.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-11-11 |
| Decision Date | 1976-11-23 |