The following data is part of a premarket notification filed by Orthopedic Equipment Co., Inc. with the FDA for Total Hip Replacement,lagrange-letournel.
| Device ID | K760651 |
| 510k Number | K760651 |
| Device Name: | TOTAL HIP REPLACEMENT,LAGRANGE-LETOURNEL |
| Classification | Prosthesis, Hip, Femoral Component, Cemented, Metal |
| Applicant | ORTHOPEDIC EQUIPMENT CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JDG |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-09-15 |
| Decision Date | 1976-10-05 |