The following data is part of a premarket notification filed by Osteoimplant Technology, Inc. with the FDA for Omega Total Hip System For Cemented Applications.
| Device ID | K960647 |
| 510k Number | K960647 |
| Device Name: | OMEGA TOTAL HIP SYSTEM FOR CEMENTED APPLICATIONS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | OSTEOIMPLANT TECHNOLOGY, INC. 11201 PEPPER RD. Hunt Valley, MD 21031 -1201 |
| Contact | John A Roberts |
| Correspondent | John A Roberts OSTEOIMPLANT TECHNOLOGY, INC. 11201 PEPPER RD. Hunt Valley, MD 21031 -1201 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-15 |
| Decision Date | 1996-09-17 |