The following data is part of a premarket notification filed by Depuy Acromed with the FDA for E-z Link Cross Connector.
Device ID | K001470 |
510k Number | K001470 |
Device Name: | E-Z LINK CROSS CONNECTOR |
Classification | Appliance, Fixation, Spinal Interlaminal |
Applicant | DEPUY ACROMED 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
Contact | Karen F Jurczak |
Correspondent | Karen F Jurczak DEPUY ACROMED 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
Product Code | KWP |
Subsequent Product Code | KWQ |
Subsequent Product Code | MNH |
Subsequent Product Code | MNI |
CFR Regulation Number | 888.3050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-05-11 |
Decision Date | 2000-08-04 |