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510(k) K011172

Device
ARTHREX BIO-TRANSFIX
Applicant
ARTHREX, INC.
510(k) number
K011172
Product code
MNU  
Decision
Substantially Equivalent (SESE)
Decision date
2001-06-19
Date received
2001-04-17
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
VERNON BROWN
Address
2885 S. Horseshoe Dr. Naples FL US 34104 34104

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
K212594OSSIOfiber® StapleOSSIO , Ltd.2022-01-21

Legacy Summary#

summary

FDA Review#

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