510(k) K181307

Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow by Zimmer, Inc. — Product Code JDC

K181307 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow". The FDA issued a decision of Substantially Equivalent on January 28, 2019. The device falls under product code JDC (Prosthesis, Elbow, Constrained, Cemented), a Class II device regulated under 21 CFR 888.3150. Zimmer, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2019
Date Received
May 17, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Elbow, Constrained, Cemented
Device Class
Class II
Regulation Number
888.3150
Review Panel
OR
Submission Type