The following data is part of a premarket notification filed by Depuy Acromed with the FDA for Moss Miami Spinal System Pin Nut.
Device ID | K023804 |
510k Number | K023804 |
Device Name: | MOSS MIAMI SPINAL SYSTEM PIN NUT |
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 | 2002-11-14 |
Decision Date | 2003-01-23 |
Summary: | summary |