The following data is part of a premarket notification filed by Signal Medical Corp. with the FDA for Rhs Acetabular Component.
| Device ID | K022382 |
| 510k Number | K022382 |
| Device Name: | RHS ACETABULAR COMPONENT |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | SIGNAL MEDICAL CORP. 3777 LAPEER RD. 3-C Port Huron, MI 48060 |
| Contact | Louis Serafin |
| Correspondent | Louis Serafin SIGNAL MEDICAL CORP. 3777 LAPEER RD. 3-C 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 | 2002-07-22 |
| Decision Date | 2002-10-04 |
| Summary: | summary |