The following data is part of a premarket notification filed by Kirschner Medical Corp. with the FDA for Kirschner Compression Hip Screw System.
| Device ID | K854205 |
| 510k Number | K854205 |
| Device Name: | KIRSCHNER COMPRESSION HIP SCREW SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | KIRSCHNER MEDICAL CORP. 9690 DEERECO ROADD Timonium, MD 21093 |
| Contact | Sanm Son |
| Correspondent | Sanm Son KIRSCHNER MEDICAL CORP. 9690 DEERECO ROADD Timonium, MD 21093 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-16 |
| Decision Date | 1985-11-19 |