The following data is part of a premarket notification filed by Depuy Acromed with the FDA for Monarch Spine System.
Device ID | K024348 |
510k Number | K024348 |
Device Name: | MONARCH SPINE SYSTEM |
Classification | Orthosis, Spondylolisthesis Spinal Fixation |
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 | MNH |
Subsequent Product Code | KWP |
Subsequent Product Code | MNI |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-12-30 |
Decision Date | 2003-01-28 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10705034063102 | K024348 | 000 |
10705034062778 | K024348 | 000 |
10705034062761 | K024348 | 000 |
10705034062754 | K024348 | 000 |
10705034062747 | K024348 | 000 |
10705034062532 | K024348 | 000 |
10705034061887 | K024348 | 000 |
10705034061870 | K024348 | 000 |
10705034061863 | K024348 | 000 |
10705034061856 | K024348 | 000 |
10705034055329 | K024348 | 000 |
10705034055305 | K024348 | 000 |
10705034055299 | K024348 | 000 |
10705034062785 | K024348 | 000 |
10705034062808 | K024348 | 000 |
10705034063096 | K024348 | 000 |
10705034063089 | K024348 | 000 |
10705034063065 | K024348 | 000 |
10705034063058 | K024348 | 000 |
10705034063041 | K024348 | 000 |
10705034063034 | K024348 | 000 |
10705034063027 | K024348 | 000 |
10705034063010 | K024348 | 000 |
10705034062846 | K024348 | 000 |
10705034062839 | K024348 | 000 |
10705034062822 | K024348 | 000 |
10705034062815 | K024348 | 000 |
10705034059808 | K024348 | 000 |