The following data is part of a premarket notification filed by Kirschner Medical Corp. with the FDA for Dimension-ha Hip Prosthesis.
| Device ID | K912922 |
| 510k Number | K912922 |
| Device Name: | DIMENSION-HA HIP PROSTHESIS |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | KIRSCHNER MEDICAL CORP. 9690 DEERECO ROADD Timonium, MD 21093 |
| Contact | Sam Son |
| Correspondent | Sam Son KIRSCHNER MEDICAL CORP. 9690 DEERECO ROADD Timonium, MD 21093 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-03 |
| Decision Date | 1991-10-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304569553 | K912922 | 000 |
| 00880304569515 | K912922 | 000 |