FDA.report

510(k) K211002

Device
Grappler Suture Anchor System
Applicant
Paragon 28, Inc.
510(k) number
K211002
Product code
MBI  
Decision
Substantially Equivalent (SESE)
Decision date
2021-07-07
Date received
2021-04-02
Regulation
888.3040
Classification name
Fastener, Fixation, Nondegradable, Soft Tissue
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
Haylie Hertz
Address
14445 Grasslands Dr. Englewood CO US 80112 80112

FDA Registration Numbers

Source Documents

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

Related GUDID Devices

Primary DIBrandCompanyPublished
00889795124265Grappler Suture Anchor SystemParagon 28, Inc.2023-01-27
00889795124258Grappler Suture Anchor SystemParagon 28, Inc.2023-01-27

Legacy Summary

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FDA Review

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