HORIZON HIP SYSTEM
Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
BIOLOGICALLY ORIENTED PROSTHESES
The following data is part of a premarket notification filed by Biologically Oriented Prostheses with the FDA for Horizon Hip System.
Pre-market Notification Details
| Device ID | K962769 |
| 510k Number | K962769 |
| Device Name: | HORIZON HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | BIOLOGICALLY ORIENTED PROSTHESES 17 SEVENTEENTH ST. Port Huron, MI 48060 |
| Contact | Cheryl L Warsinske |
| Correspondent | Cheryl L Warsinske BIOLOGICALLY ORIENTED PROSTHESES 17 SEVENTEENTH ST. Port Huron, MI 48060 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-16 |
| Decision Date | 1996-10-03 |
| Summary: | summary |
Trademark Results [HORIZON HIP SYSTEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HORIZON HIP SYSTEM 75548621 2331351 Dead/Cancelled |
Signal Medical Corporation 1998-09-02 |
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