G7® Vivacit-E® Freedom® Constrained Liner
K-Number: K212512 · 2022-04-28
ApplicantZimmer, Inc.
Decision Date2022-04-28
Product CodePBI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
G7® Vivacit-E® Freedom® Constrained Liner is a medical device manufactured by Zimmer, Inc.. It received FDA 510(k) clearance on 2022-04-28 under approval number K212512. The device is classified under product code PBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the G7® Vivacit-E® Freedom® Constrained Liner?
G7® Vivacit-E® Freedom® Constrained Liner is a medical device that received FDA 510(k) clearance on 2022-04-28. It is manufactured by Zimmer, Inc.. The 510(k) number is K212512.
When was G7® Vivacit-E® Freedom® Constrained Liner approved by the FDA?
G7® Vivacit-E® Freedom® Constrained Liner received FDA 510(k) clearance on 2022-04-28, under approval number K212512.
What company makes G7® Vivacit-E® Freedom® Constrained Liner?
G7® Vivacit-E® Freedom® Constrained Liner is manufactured by Zimmer, Inc..
What is the FDA product code for G7® Vivacit-E® Freedom® Constrained Liner?
The FDA product code for G7® Vivacit-E® Freedom® Constrained Liner is PBI.
Other Devices by Zimmer, Inc.
K161830Zimmer M/L Taper Hip Prosthesis
K151716Cable-Ready Cable Grip System: Cable-Ready Bone Plate System
K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System
K172767Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid
K172114Zimmer Natural Nail System
K181761Zimmer Biomet Select Ceramic Heads
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.