The following data is part of a premarket notification filed by Depuy Acromed with the FDA for Moss Miami 6.35mm Rod System Monoaxial Screws, Polyaxial Reduction Screws And Sacral Extenders.
| Device ID | K002607 |
| 510k Number | K002607 |
| Device Name: | MOSS MIAMI 6.35MM ROD SYSTEM MONOAXIAL SCREWS, POLYAXIAL REDUCTION SCREWS AND SACRAL EXTENDERS |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | DEPUY ACROMED 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Lisa Gilman |
| Correspondent | Lisa Gilman DEPUY ACROMED 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-22 |
| Decision Date | 2000-09-12 |