The following data is part of a premarket notification filed by Acromed Corp. with the FDA for Acromed Cross Rod Connector.
Device ID | K874882 |
510k Number | K874882 |
Device Name: | ACROMED CROSS ROD CONNECTOR |
Classification | Appliance, Fixation, Spinal Interlaminal |
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 | KWP |
CFR Regulation Number | 888.3050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-01 |
Decision Date | 1988-02-18 |