The following data is part of a premarket notification filed by Osteoimplant Technology, Inc. with the FDA for Z - Series Modular Total Hip System Plasma Coated.
| Device ID | K040685 |
| 510k Number | K040685 |
| Device Name: | Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, 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 | LWJ |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWL |
| Subsequent Product Code | KWY |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-16 |
| Decision Date | 2005-01-25 |