The following data is part of a premarket notification filed by Osteoimplant Technology, Inc. with the FDA for Omega Ii Modular Total Hip System.
| Device ID | K984227 |
| 510k Number | K984227 |
| Device Name: | OMEGA II MODULAR TOTAL HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| 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 | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-25 |
| Decision Date | 1999-04-08 |