The following data is part of a premarket notification filed by Signal Medical Corp. with the FDA for Smc 28mm Ceramic Femoral Heads.
| Device ID | K981302 |
| 510k Number | K981302 |
| Device Name: | SMC 28MM CERAMIC FEMORAL HEADS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | SIGNAL MEDICAL CORP. 3315 BERRY DR. Lakeport, MI 48059 |
| Contact | Louis A Serafin, Jr. |
| Correspondent | Louis A Serafin, Jr. SIGNAL MEDICAL CORP. 3315 BERRY DR. Lakeport, MI 48059 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-09 |
| Decision Date | 1998-06-25 |
| Summary: | summary |