510(k) K837776

AOR X-RAY ALIGMENT PAD by Zimmer, Inc. — Product Code IXJ

K837776 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "AOR X-RAY ALIGMENT PAD". The FDA issued a decision of Substantially Equivalent on August 18, 1983. The device falls under product code IXJ (Grid, Radiographic), a Class I device regulated under 21 CFR 892.1910. Zimmer, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1983
Date Received
January 1, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Grid, Radiographic
Device Class
Class I
Regulation Number
892.1910
Review Panel
RA
Submission Type