The following data is part of a premarket notification filed by Osteoimplant Technology, Inc. with the FDA for Lsf Ha Coated Triad Total Hip System.
| Device ID | K974506 |
| 510k Number | K974506 |
| Device Name: | LSF HA COATED TRIAD TOTAL HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | OSTEOIMPLANT TECHNOLOGY, INC. 11201 PEPPER RD. Hunt Valley, MD 21031 -1201 |
| Contact | San Son |
| Correspondent | San 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 | 1997-12-01 |
| Decision Date | 1998-02-27 |