FDA.reportPublic FDA data

ISOTIS ORTHOBIOLOGICS, INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20900103001503333ISOTIS ORTHOBIOLOGICS, INC1N2026-01-012 Goodyear IRVINE CA US 92618

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1843821879915904K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsOLO2025-04-02
1843821401750274K242273Cove Putty, OsteoCove PuttyMQV2024-09-25
1843821510328044K232668Cove Strip, OsteoCove StripMQV2023-09-27
1843821133132243K231030Cove Putty, OsteoCove PuttyMQV2023-09-14
1843821273537694K230486Cove StripMQV2023-08-21
1843821757670707K212135Dry DBM- A PuttyMQV2021-10-04
1843821238658169K200290Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT)MQV2020-05-11
1843821982554188K193040Resorbable Mesh DeviceMQV2019-11-30
1843821263067496K181958MagnetOs PuttyMQV2018-12-06
1843821425845943K172130Resorbable Mesh DeviceMQV2017-11-16
1843822035911485K103742ACCELL EVO3 (FORMERLY ACCELL A2I)MBP2011-03-17
1843821234006147K091193ACCELL EVO3CMBP2009-08-10
1843821127547924K070751ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTYMQV2007-10-15
1843821844345468K063124INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPSMQV2007-01-19
1843821086103238K062353MOZAIK BONE REGENERATION MATRIX - PUTTYMQV2006-12-20
1843821454450060K061880ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CCMQV2007-08-15
1843821834112585K060332ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTYNUN2006-03-29
1843821573957332K052098CONNEXUS, .5CC, MODEL 023000-005MQV2005-09-07
1843821845976672K050690CONNEXUSMQV2005-07-07
1843821026812026K050642ORTHOBLAST II PUTTY AND PASTEMBP2005-12-05
1843821734790014K040419DYNAGRAFT IIMQV2005-03-25
1843821383127745K031826TRIHA +MQV2003-11-28
1843821129654004
1843821282448423
1843821286477758

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MQV172024-09-25
MBP32011-03-17
OLO12025-04-02
NUN12006-03-29

PMN#