The following data is part of a premarket notification filed by Acromed Corp. with the FDA for Acromed/kaneda Anterior Spinal Instrumentation.
Device ID | K873826 |
510k Number | K873826 |
Device Name: | ACROMED/KANEDA ANTERIOR SPINAL INSTRUMENTATION |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | ACROMED CORP. BUCKMAN COMPANY, INC. 921 CALLE VERDE Martinez, CA 94553 |
Contact | David W Schlerf |
Correspondent | David W Schlerf ACROMED CORP. BUCKMAN COMPANY, INC. 921 CALLE VERDE Martinez, CA 94553 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-23 |
Decision Date | 1988-11-30 |