The following data is part of a premarket notification filed by Depuy Acromed with the FDA for 5.0 Mm Diameter Polyaxial Screws (moss Miami 6.35mm System).
| Device ID | K022623 |
| 510k Number | K022623 |
| Device Name: | 5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM) |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | DEPUY ACROMED 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Frank Maas |
| Correspondent | Frank Maas 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 | 2002-08-07 |
| Decision Date | 2002-08-27 |
| Summary: | summary |