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510(k) K212594

Device
OSSIOfiber® Staple
Applicant
OSSIO Ltd.
510(k) number
K212594
Product code
MNU  
Decision
Substantially Equivalent (SESE)
Decision date
2022-01-21
Date received
2021-08-16
Regulation
888.3030
Classification name
Staple, Absorbable
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Taly Linder
Address
8 Hatochen St. Caesarea IL 3079861 3079861

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MNU  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K241932OSSIOfiber® Compression StapleOSSIO , Ltd.2024-08-28
K233302OSSIOfiber® Compression StapleOSSIO , Ltd.2023-11-16
K011172ARTHREX BIO-TRANSFIXArthrex, Inc.2001-06-19

Legacy Summary#

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FDA Review#

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