The following data is part of a premarket notification filed by Cintor Orthopaedic Div. with the FDA for Radial Head Prosthesis.
| Device ID | K811451 |
| 510k Number | K811451 |
| Device Name: | RADIAL HEAD PROSTHESIS |
| Classification | Prosthesis, Elbow, Semi-constrained, Cemented |
| Applicant | CINTOR ORTHOPAEDIC DIV. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JDB |
| CFR Regulation Number | 888.3160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-22 |
| Decision Date | 1981-06-09 |