The following data is part of a premarket notification filed by Kirschner Medical Corp. with the FDA for Kirschner Intramedullary Nail System.
| Device ID | K854338 |
| 510k Number | K854338 |
| Device Name: | KIRSCHNER INTRAMEDULLARY NAIL SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| 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 | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-28 |
| Decision Date | 1985-12-09 |