The following data is part of a premarket notification filed by Signal Medical Corp. with the FDA for Signal Medical Corporation Beacon Knee System.
| Device ID | K051510 |
| 510k Number | K051510 |
| Device Name: | SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | SIGNAL MEDICAL CORP. 400 PYRAMID DR. Marysville, MI 48040 |
| Contact | Louis A Serafin |
| Correspondent | Louis A Serafin SIGNAL MEDICAL CORP. 400 PYRAMID DR. Marysville, MI 48040 |
| Product Code | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-07 |
| Decision Date | 2006-03-22 |