The following data is part of a premarket notification filed by Osteoimplant Technology, Inc. with the FDA for Omega Total Hip System For Use Without Bone Cement (line Extension).
| Device ID | K964924 |
| 510k Number | K964924 |
| Device Name: | OMEGA TOTAL HIP SYSTEM FOR USE WITHOUT BONE CEMENT (LINE EXTENSION) |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | OSTEOIMPLANT TECHNOLOGY, INC. 11201 PEPPER RD. Hunt Valley, MD 21031 -1201 |
| Contact | Sam Son |
| Correspondent | Sam Son OSTEOIMPLANT TECHNOLOGY, INC. 11201 PEPPER RD. Hunt Valley, MD 21031 -1201 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-09 |
| Decision Date | 1997-03-07 |