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Data / Medical devices / United States / Cgbio Usa, Inc.

Cgbio Usa, Inc.: FDA-registered device maker in Irvine, CA, United States, 31 510(k) clearances

Cgbio Usa, Inc. is registered with the FDA (registration 3039103971) in Irvine, CA, United States. It lists 26 device types. The FDA files 31 510(k) clearances under its listings, the newest dated April 9, 2026. 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 Cgbio Usa, Inc.
FDA registration number
3039103971
Address
41 Corporate Park Ste 200, Irvine, CA, United States, 92606
Owner or operator
CGBIO USA, Inc. (10094982)
Roles
Repackager or relabeler
First device listed
January 27, 2026
Registered through
2027
Brand names listed
ANAX™ 5.5 CT Spinal System, ANAX™ 5.5 SPINAL SYSTEM, ANAX™ OCT SPINAL SYSTEM, ASPIRON S ACP SYSTEM, ASPIRON™ ACP SYSTEM, Benefix™ Interspinous Fixation System, Dyna Locking Trochanteric Nail, Dyna Locking Trochanteric Nail™ and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal InterlaminalKWP2Repackager or relabeleraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Repackager or relabeleraccessdata.fda.gov
Bit, DrillHTW1Repackager or relabeleraccessdata.fda.gov
Chisel, Surgical, ManualFZO1Repackager or relabeleraccessdata.fda.gov
Curette, Surgical, General UseFZS1Repackager or relabeleraccessdata.fda.gov
Elevator, Surgical, General & Plastic SurgeryGEG1Repackager or relabeleraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Repackager or relabeleraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Repackager or relabeleraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, CervicalOVE2Repackager or relabeleraccessdata.fda.gov
Knife, OrthopedicHTS1Repackager or relabeleraccessdata.fda.gov
MalletHXL1Repackager or relabeleraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Repackager or relabeleraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Repackager or relabeleraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Repackager or relabeleraccessdata.fda.gov
Pin, Fixation, SmoothHTY2Repackager or relabeleraccessdata.fda.gov
Plate, Cranioplasty, Preformed, Non-AlterableGXN2Repackager or relabeleraccessdata.fda.gov
Posterior Cervical Screw SystemNKG2Repackager or relabeleraccessdata.fda.gov
Punch, SurgicalLRY1Repackager or relabeleraccessdata.fda.gov
ReamerHTO1Repackager or relabeleraccessdata.fda.gov
RetractorGAD1Repackager or relabeleraccessdata.fda.gov
Rod, Fixation, Intramedullary And AccessoriesHSB2Repackager or relabeleraccessdata.fda.gov
RongeurHTX1Repackager or relabeleraccessdata.fda.gov
ScrewdriverHXX1Repackager or relabeleraccessdata.fda.gov
Spinous Process PlatePEK2Repackager or relabeleraccessdata.fda.gov
System, Facet Screw Spinal DeviceMRWURepackager or relabeleraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Repackager or relabeleraccessdata.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 9, 2026K252251EASYMADE-TIGXNSubstantially EquivalentCG Bio Co., Ltd.accessdata.fda.gov
October 28, 2025K252351UniSpace® TPLIF CageMAXSubstantially EquivalentCg Medtech Co., Ltd.accessdata.fda.gov
June 25, 2025K251725ANAX™ OCT Spinal SystemNKGSubstantially EquivalentCg Medtech Co., Ltd.accessdata.fda.gov
April 19, 2024K234119UniSpace® Stand-Alone C CageOVESubstantially EquivalentInnosys Co., Ltd.accessdata.fda.gov
February 6, 2024K233960INNOVERSE Spinal SystemNKBSubstantially EquivalentInnosys Co., Ltd.accessdata.fda.gov
October 26, 2023K231737ANAX™ 5.5 Spinal SystemNKBSubstantially EquivalentInnosys Co., Ltd.accessdata.fda.gov
March 3, 2023K221084Dyna Locking Trochanteric Nail™HSBSubstantially EquivalentInnosysaccessdata.fda.gov
November 19, 2021K210573Velofix SA Cervical CageOVESubstantially EquivalentU&I Corporationaccessdata.fda.gov
July 10, 2019K183243Velofix TLIF CageMAXSubstantially EquivalentU&I Corporationaccessdata.fda.gov
February 1, 2019K190053SECULOK™ ACP SystemKWQSubstantially EquivalentU&I Corporationaccessdata.fda.gov
December 13, 2018K181824CBT Screw Fixation SystemNKBSubstantially EquivalentU&I Corporationaccessdata.fda.gov
December 12, 2018K183383ANAX™ OCT Spinal SystemNKGSubstantially EquivalentU&I Corporationaccessdata.fda.gov
November 14, 2018K181829Velofix TLIF CageMAXSubstantially EquivalentU&I Corporationaccessdata.fda.gov
January 3, 2018K173198Facet Screw Fixation SystemMRWSubstantially EquivalentU&I Corporationaccessdata.fda.gov
December 13, 2017K173524ANAX 5.5™ Spinal SystemNKBSubstantially EquivalentU&I Corporationaccessdata.fda.gov
December 4, 2017K172419Velofix™ TLIF CageMAXSubstantially EquivalentU&I Corporationaccessdata.fda.gov
November 22, 2017K172424Velofix™ SA Cervical CageOVESubstantially EquivalentU&I Corporationaccessdata.fda.gov
July 13, 2017K171749Velofix(tm) Interbody Fusion SystemODPSubstantially EquivalentU&I Corporationaccessdata.fda.gov
August 30, 2016K162189ANAX™ 5.5 Spinal SystemMNHSubstantially EquivalentU&I Corporationaccessdata.fda.gov
September 3, 2015K143631Benefix Interspinous Fixation SystemPEKSubstantially EquivalentU&I Corporationaccessdata.fda.gov
June 3, 2015K150570ANAX OCT Spinal SystemNKGSubstantially EquivalentU&I Corporationaccessdata.fda.gov
February 25, 2015K143417ANAX 5.5 Spinal SystemMNHSubstantially EquivalentU&I Corporationaccessdata.fda.gov
July 22, 2014K140864VELOXTM INTERBODY FUSION SYSTEMODPSubstantially EquivalentU&I Corp.accessdata.fda.gov
June 2, 2014K140234ASPIRON ACP SYSTEMKWQSubstantially EquivalentU&I Corp.accessdata.fda.gov
March 5, 2014K132926VELOFIXTM INTERBODY FUSION SYSTEMODPSubstantially EquivalentU&I Corp.accessdata.fda.gov
December 17, 2013K132218PERFIX ILIAC SCREW SYSTEMMNHSubstantially EquivalentU&I Corporationaccessdata.fda.gov
November 25, 2013K132101ANAX 5.5 SPINAL SYSTEMMNHSubstantially EquivalentU&I Corporationaccessdata.fda.gov
August 29, 2013K131200ASPIRON ACP SYSTEMKWQSubstantially EquivalentU&I Corporationaccessdata.fda.gov
June 23, 2010K093707DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820HSBSubstantially EquivalentU&I Corp.accessdata.fda.gov
December 2, 2009K092771DYNA LOCKING IM NAILHSBSubstantially EquivalentU&I Corp.accessdata.fda.gov
November 9, 2009K091725PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549)MNHSubstantially EquivalentU&I Corp.accessdata.fda.gov

Compare with other makers

Updated April 9, 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.