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510(k) K153208

Device
Internal Joint Stabilizer - Elbow
Applicant
SKELETAL DYNAMICS, LLC
510(k) number
K153208
Product code
OZI  
Decision
Substantially Equivalent (SESE)
Decision date
2015-12-31
Date received
2015-11-05
Regulation
888.3030
Classification name
Internal Hinged Elbow Fixator
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Ana M Escagedo
Address
8905 SW 87 Ave., Suite 201 Miami FL US 33176 33176

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OZI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K231447Double Internal Joint Stabilizer- ElbowSkeletal Dynamics, Inc.2023-12-15
K223318Internal Joint Stabilizer - ElbowSkeletal Dynamics, Inc.2023-05-10

Legacy Summary#

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FDA Review#

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