The following data is part of a premarket notification filed by Mecron Medical Products, Inc. with the FDA for Autodynamic Compression Hip Screw-plate.
| Device ID | K843449 |
| 510k Number | K843449 |
| Device Name: | AUTODYNAMIC COMPRESSION HIP SCREW-PLATE |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | MECRON MEDICAL PRODUCTS, INC. P.O. BOX 1139 Port Washington , NY 11050 - |
| Contact | Emmanuel Anapliotis |
| Correspondent | Emmanuel Anapliotis MECRON MEDICAL PRODUCTS, INC. P.O. BOX 1139 Port Washington , NY 11050 - |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-05 |
| Decision Date | 1984-10-22 |