FDA.reportPublic FDA data

ISOTIS ORTHOBIOLOGICS, INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20900103001503333ISOTIS ORTHOBIOLOGICS, INC1N2027-01-012 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
1843821033529211
1843821123848052
1843821161489845
1843821282448423
1843821286477758
1843821324961667
1843821409591657
1843821429225876
1843821440119854
1843821480674308
1843821486508979
1843821559896753
1843821560201395
1843821572583876
1843821586689499
1843821606264327
1843821617881098
1843821663803097
1843821695557331
1843821727792353
1843821765039991
1843821848184121
1843821915021541
1843821945688887
1843821967359590
1843821976043417
1843822001366387
1843822010292593
1843822045961311
1843822056519882
1843822069144955

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#