FDA.report

510(k) K210016

Device
Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,Ne
Applicant
Integra Lifesciences Corporation
510(k) number
K210016
Product code
HRS  
Decision
Substantially Equivalent (SESE)
Decision date
2021-07-27
Date received
2021-01-04
Regulation
888.3030
Classification name
Plate, Fixation, Bone
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
Blesson Abraham
Address
11101 Metric Blvd. Austin TX US 78758 78758

FDA Registration Numbers

Source Documents

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

Related GUDID Devices

Primary DIBrandCompanyPublished
00885556865897Subtalar MBA Implant SystemSmith & Nephew, Inc.2022-12-22
00885556865880Subtalar MBA Implant SystemSmith & Nephew, Inc.2022-12-22
00885556865910Subtalar MBA Implant SystemSmith & Nephew, Inc.2022-12-19
00885556865903Subtalar MBA Implant SystemSmith & Nephew, Inc.2022-12-19
00885556865873Subtalar MBA Implant SystemSmith & Nephew, Inc.2022-12-19

Legacy Summary

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FDA Review

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