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510(k) K212512

Device
G7® Vivacit-E® Freedom® Constrained Liner
Applicant
Zimmer, Inc.
510(k) number
K212512
Product code
PBI  
Decision
Substantially Equivalent (SESE)
Decision date
2022-04-28
Date received
2021-08-10
Regulation
888.3310
Classification name
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer, + Additive
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Romil Sheth
Address
1800 W. Center St. Warsaw IN US 46580 46580

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PBI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K121874G7 ACETABULAR SYSTEMBiomet Manufacturing Corp2012-11-23

Legacy Summary#

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FDA Review#

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