The following data is part of a premarket notification filed by Signal Medical Corp. with the FDA for Smc Acetabular Component.
| Device ID | K971018 |
| 510k Number | K971018 |
| Device Name: | SMC ACETABULAR COMPONENT |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | SIGNAL MEDICAL CORP. 3315 BERRY DR. Lakeport, MI 48059 |
| Contact | Louis A Serafin |
| Correspondent | Louis A Serafin SIGNAL MEDICAL CORP. 3315 BERRY DR. Lakeport, MI 48059 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-20 |
| Decision Date | 1997-10-24 |
| Summary: | summary |