The following data is part of a premarket notification filed by Signal Medical Corp. with the FDA for Smc Femoral Hip Component.
| Device ID | K971681 |
| 510k Number | K971681 |
| Device Name: | SMC FEMORAL HIP COMPONENT |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| 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 | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-06 |
| Decision Date | 1997-12-04 |
| Summary: | summary |