The following data is part of a premarket notification filed by Kirschner Medical Corp. with the FDA for Dimension Total Hip Prosthesis Porous Coated.
| Device ID | K854107 |
| 510k Number | K854107 |
| Device Name: | DIMENSION TOTAL HIP PROSTHESIS POROUS COATED |
| Classification | Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) |
| Applicant | KIRSCHNER MEDICAL CORP. 9690 DEERECO ROADD Timonium, MD 21093 |
| Contact | San Son |
| Correspondent | San Son KIRSCHNER MEDICAL CORP. 9690 DEERECO ROADD Timonium, MD 21093 |
| Product Code | JDL |
| CFR Regulation Number | 888.3320 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-08 |
| Decision Date | 1986-03-10 |