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510(k) K242799

Device
PliaFX Flo
Applicant
Lifenet Health
510(k) number
K242799
Product code
MBP
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-21
Date received
2024-09-17
Regulation
888.3045
Classification name
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Brittany Beasley
Address
1864 Concert Dr. Virginia Beach VA US 23453 23453

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MBP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K143547Vivorte Trabexus EBVivorte, Inc.2015-01-14
K130703VIVORTE BVFVivorte, Inc.2013-09-12
K130498OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTYBacterin International, Inc.2013-05-31
K122513CLEARED UNDER GRAFTON II EDBMMedtronic Sofamor Danek, Inc.2013-03-06
K113728SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTYHans Biomed Corp.2012-11-15
K103742ACCELL EVO3 (FORMERLY ACCELL A2I)Integra Life Sciences2011-03-17
K091193ACCELL EVO3CIsotis Orthobiologics, Inc.2009-08-10
K080399DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTEMusculoskeletal Transplant Foundation2008-10-10
K081817ACCELL TBM-RIsotis Orthobiologics, Inc.2008-09-24
K080405SYGNAL DBMMusculoskeletal Transplant Foundation2008-08-28
K080329CAP PLUS, EQUIVABONE, CAP/DBMEtex Corp.2008-04-28
K073329SYGNAL DBMMusculoskeletal Transplant Foundation2008-02-28
K063685OPTECURE; OPTECURE + CCCExactech, Inc.2007-06-07
K063676DBX DEMINERALIZED BONE MATRIX MIXMusculoskeletal Transplant Foundation2007-03-05
K061131DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTYOrthocon, Inc.2007-02-08