The following data is part of a premarket notification filed by Mecron Medical Products, Inc. with the FDA for Mecron Cemented Structured Stem Hip Prosthesis.
| Device ID | K844488 |
| 510k Number | K844488 |
| Device Name: | MECRON CEMENTED STRUCTURED STEM HIP PROSTHESIS |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Applicant | MECRON MEDICAL PRODUCTS, INC. 2049 CENTURY PARK EAST #1200 TWO CENTURY PLAZA Los Angeles, CA 90067 |
| Contact | Jay H Geller |
| Correspondent | Jay H Geller MECRON MEDICAL PRODUCTS, INC. 2049 CENTURY PARK EAST #1200 TWO CENTURY PLAZA Los Angeles, CA 90067 |
| Product Code | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-19 |
| Decision Date | 1985-03-12 |