510(k) K203218

CaP Spheres Pellet Pack by Zimmer Biomet Spine, Inc. — Product Code MQV

K203218 is an FDA 510(k) premarket notification submitted by Zimmer Biomet Spine, Inc. for the device "CaP Spheres Pellet Pack". The FDA issued a decision of Substantially Equivalent on May 4, 2021. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Zimmer Biomet Spine, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2021
Date Received
November 2, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filler, Bone Void, Calcium Compound
Device Class
Class II
Regulation Number
888.3045
Review Panel
OR
Submission Type