FDA.report

510(k) K161189

Device
Integra TITAN Reverse Shoulder System
Applicant
INTEGRA LIFESCIENCES CORPORATION
510(k) number
K161189
Product code
PHX  
Decision
Substantially Equivalent (SESE)
Decision date
2016-08-25
Date received
2016-04-27
Regulation
888.3660
Classification name
Shoulder Prosthesis, Reverse Configuration
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
William Garzon
Address
8700 Cameron Rd., Suite 100 Austin TX US 78754 78754

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
00885556863510Titan Reverse Shoulder SystemSmith & Nephew, Inc.2022-12-21

Legacy Summary

summary

FDA Review

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