510(k) K843219

ZIMMER BONE CEMENT CENTRIFUGATION SYS by Zimmer, Inc. — Product Code JDZ

K843219 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "ZIMMER BONE CEMENT CENTRIFUGATION SYS". The FDA issued a decision of Substantially Equivalent on November 29, 1984. The device falls under product code JDZ (Mixer, Cement, For Clinical Use), a Class I device regulated under 21 CFR 888.4210. Zimmer, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1984
Date Received
August 15, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mixer, Cement, For Clinical Use
Device Class
Class I
Regulation Number
888.4210
Review Panel
OR
Submission Type