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510(k) K200290

Device
Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT)
Applicant
SeaSpine Orthopedics Corporation
510(k) number
K200290
Product code
MBP  
Decision
Substantially Equivalent (SESE)
Decision date
2020-05-11
Date received
2020-02-05
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
Caryn Sailor
Address
2 Goodyear Irvine CA US 92618 92618

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
K242799PliaFX FloLifenet Health2024-11-21
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

Legacy Summary#

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FDA Review#

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