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 | K000817 |
| 510k Number | K000817 |
| 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 | 2000-03-13 |
| Decision Date | 2000-06-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912076678 | K000817 | 000 |
| 00888912088329 | K000817 | 000 |
| 00888912088336 | K000817 | 000 |
| 00888912088350 | K000817 | 000 |
| 00888912088367 | K000817 | 000 |
| 00888912088374 | K000817 | 000 |
| 00888912088381 | K000817 | 000 |
| 00888912088404 | K000817 | 000 |
| 00888912088411 | K000817 | 000 |
| 00888912088428 | K000817 | 000 |
| 00888912088435 | K000817 | 000 |
| 00888912076579 | K000817 | 000 |
| 00888912076593 | K000817 | 000 |
| 00888912076616 | K000817 | 000 |
| 00888912076630 | K000817 | 000 |
| 00888912076654 | K000817 | 000 |
| 00888912088312 | K000817 | 000 |