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Data / Medical devices / United States / Isotis Orthobiologics, Inc

Isotis Orthobiologics, Inc: FDA-registered device maker in Irvine, CA, United States, 21 510(k) clearances

Isotis Orthobiologics, Inc is registered with the FDA (registration 2090010) in Irvine, CA, United States. It lists 11 device types. The FDA files 21 510(k) clearances under its listings, the newest dated April 2, 2025. 3 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Isotis Orthobiologics, Inc
FDA registration number
2090010
FEI number
3001503333
Address
2 Goodyear, Irvine, CA, United States, 92618
Owner or operator
SeaSpine Orthopedics Corporation (10049589)
Roles
Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
First device listed
June 24, 2015
Registered through
2027
Brand names listed
Accell Connexus, Accell Connexus Keystone Dental, Accell Evo3 (formerly (A2), Accell Evo3 (formerly A2), Accell Evo3C, Accell TBM, AlloSync CB DBM, AlloSync CB DBM Paste and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Contract manufactureraccessdata.fda.gov
Bone Grafting Material, Human SourceNUN2Contract manufacturer, Manufactureraccessdata.fda.gov
Filler, Bone Void, Calcium CompoundMQV2Complaint file establishment, Manufactureraccessdata.fda.gov
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)MBP2Complaint file establishment, Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Contract manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Contract manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, ThoracicPHM2Contract manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, CervicalOVE2Contract manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2Contract manufactureraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Spinal Vertebral Body Replacement DeviceMQP2Contract manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
April 2, 2025K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsOLOSubstantially EquivalentSeaSpine Orthopedics Corporationaccessdata.fda.gov
September 25, 2024K242273Cove Putty, OsteoCove PuttyMQVSubstantially EquivalentSeaSpine Orthopedics Corporationaccessdata.fda.gov
September 27, 2023K232668Cove Strip, OsteoCove StripMQVSubstantially EquivalentSeaSpine Orthopedics Corporationaccessdata.fda.gov
September 14, 2023K231030Cove Putty, OsteoCove PuttyMQVSubstantially EquivalentSeaSpine Orthopedics Corporationaccessdata.fda.gov
August 21, 2023K230486Cove StripMQVSubstantially EquivalentSeaSpine Orthopedics Corporationaccessdata.fda.gov
October 4, 2021K212135Dry DBM- A PuttyMQVSubstantially EquivalentSeaspine Corporationaccessdata.fda.gov
May 11, 2020K200290Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT)MQVSubstantially EquivalentSeaSpine Orthopedics Corporationaccessdata.fda.gov
November 30, 2019K193040Resorbable Mesh DeviceMQVSubstantially EquivalentSeaSpine Orthopedics Corporationaccessdata.fda.gov
December 6, 2018K181958MagnetOs PuttyMQVSubstantially EquivalentKuros Biosciences B.Vaccessdata.fda.gov
November 16, 2017K172130Resorbable Mesh DeviceMQVSubstantially EquivalentSeaSpine Orthopedics Corporationaccessdata.fda.gov
March 17, 2011K103742ACCELL EVO3 (FORMERLY ACCELL A2I)MBPSubstantially EquivalentIntegra Life Sciencesaccessdata.fda.gov
August 10, 2009K091193ACCELL EVO3CMBPSubstantially EquivalentIsotis Orthobiologics, Inc.accessdata.fda.gov
October 15, 2007K070751ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTYMQVSubstantially EquivalentIsotis Orthobiologics, Inc.accessdata.fda.gov
August 15, 2007K061880ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CCMQVSubstantially EquivalentIsotis NVaccessdata.fda.gov
January 19, 2007K063124INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPSMQVSubstantially EquivalentIntegra Lifesciences Corp.accessdata.fda.gov
December 20, 2006K062353MOZAIK BONE REGENERATION MATRIX - PUTTYMQVSubstantially EquivalentIntegra LifeSciences Corporationaccessdata.fda.gov
March 29, 2006K060332ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTYNUNSubstantially EquivalentIsotis NVaccessdata.fda.gov
December 5, 2005K050642ORTHOBLAST II PUTTY AND PASTEMBPSubstantially EquivalentIsotis Orthobiologics, Inc.accessdata.fda.gov
September 7, 2005K052098CONNEXUS, .5CC, MODEL 023000-005MQVSubstantially EquivalentIsotis Orthobiologics, Inc.accessdata.fda.gov
July 7, 2005K050690CONNEXUSMQVSubstantially EquivalentIsotis Orthobiologics, Inc.accessdata.fda.gov
March 25, 2005K040419DYNAGRAFT IIMQVSubstantially EquivalentIsotis Orthobiologics, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
July 2, 202699332Class IIOngoingOsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc DBM (fill for 45 11 mm configuration) instead of approx. 7.5 cc DBM (fill for 45 17.5 mm configuration), which may lead to delayed fusion, incomplete fusion, pseudarthrosis, or laaccessdata.fda.gov
November 27, 202495981Class IIOngoingOsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.accessdata.fda.gov
November 27, 202495978Class IIOngoingOsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.accessdata.fda.gov

Compare with other makers

Updated July 28, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.