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Data / Medical devices / United States / AVALIGN TECHNOLOGIES, Inc.

AVALIGN TECHNOLOGIES, Inc.: FDA-registered device maker in Fort Wayne, IN, United States, 11 510(k) clearances

AVALIGN TECHNOLOGIES, Inc. is registered with the FDA (registration 3008864603) in Fort Wayne, IN, United States. It lists 36 device types. The FDA files 11 510(k) clearances under its listings, the newest dated June 18, 2026. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch AVALIGN TECHNOLOGIES, Inc.
FDA registration number
3008864603
Address
8727 Clinton Park Dr, Fort Wayne, IN, United States, 46825
Owner or operator
Avalign Technologies (10051835)
Roles
Specification developer
First device listed
May 9, 2016
Registered through
2027

Devices it lists

DeviceProduct codeClassRoleSource
Bit, DrillHTW1Specification developeraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Specification developeraccessdata.fda.gov
Clamp, VascularDXC2Specification developeraccessdata.fda.gov
CuretteHTF1Specification developeraccessdata.fda.gov
Dilator, Vessel, SurgicalDWP2Specification developeraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Specification developeraccessdata.fda.gov
Elevator, Surgical, General & Plastic SurgeryGEG1Specification developeraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Specification developeraccessdata.fda.gov
Forceps, ObstetricalHDA2Specification developeraccessdata.fda.gov
Forceps, Surgical, GynecologicalHCZ2Specification developeraccessdata.fda.gov
Handle, ScalpelGDZ1Specification developeraccessdata.fda.gov
Hook, Surgical, General & Plastic SurgeryGDG1Specification developeraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, CervicalOVE2Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2Specification developeraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Specification developeraccessdata.fda.gov
Mallet, Surgical, General & Plastic SurgeryGFJ1Specification developeraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Specification developeraccessdata.fda.gov
Orthopedic TrayOJH1Specification developeraccessdata.fda.gov
OsteotomeHWM1Specification developeraccessdata.fda.gov
Osteotome, ManualGFI1Specification developeraccessdata.fda.gov
Probe And Director, Gastro-UrologyFGM1Specification developeraccessdata.fda.gov
RaspHTR1Specification developeraccessdata.fda.gov
Rasp, Surgical, General & Plastic SurgeryGAC1Specification developeraccessdata.fda.gov
ReamerHTO1Specification developeraccessdata.fda.gov
RetractorGAD1Specification developeraccessdata.fda.gov
Retractor, Self-Retaining, For NeurosurgeryGZT2Specification developeraccessdata.fda.gov
RongeurHTX1Specification developeraccessdata.fda.gov
Rongeur, ManualHAE2Specification developeraccessdata.fda.gov
Scissors, General, SurgicalLRW1Specification developeraccessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other AccessoriesKCT2Specification developeraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Specification developeraccessdata.fda.gov
TemplateHWT1Specification developeraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Specification developeraccessdata.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
June 18, 2026K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemOVESubstantially EquivalentAvalign Technologies, Inc.accessdata.fda.gov
July 10, 2025K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemOVDSubstantially EquivalentAvalign Technologies, Inc.accessdata.fda.gov
August 6, 2020K193066Steripack cases and Tray SystemsKCTSubstantially EquivalentAvalign Technologies, Inc.accessdata.fda.gov
August 31, 2010K100518INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054DWPSubstantially EquivalentInstrumed International, Inc.accessdata.fda.gov
April 29, 2010K100517INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXXHDASubstantially EquivalentInstrumed International, Inc.accessdata.fda.gov
December 3, 2009K092840INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICALHCZSubstantially EquivalentInstrumed International, Inc.accessdata.fda.gov
October 26, 2009K092544INSTRUMED VASCULAR CLAMPSDXCSubstantially EquivalentInstrumed International, Inc.accessdata.fda.gov
August 8, 2008K081651INSTRUMED RONGEURHAESubstantially EquivalentInstrumed International, Inc.accessdata.fda.gov
August 2, 2007K071771INSTRUMED RETRACTORSGZTSubstantially EquivalentInstrumed International, Inc.accessdata.fda.gov
April 16, 2004K040855INSTRUMED LAPAROSCOPE AND ACCESSORIESGEISubstantially EquivalentInstrumed International, Inc.accessdata.fda.gov
March 7, 1997K962545DENTAL, MEDICAL INSTRUMENT CASES & CASSETTEKCTSubstantially EquivalentSterilization Cassette Systems, Inc.accessdata.fda.gov

Compare with other makers

Updated June 18, 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.