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Data / Medical devices / United States / Nvision Biomedical Technologies, Inc

Nvision Biomedical Technologies, Inc: FDA-registered device maker in San Antonio, TX, United States, 31 510(k) clearances

Nvision Biomedical Technologies, Inc is registered with the FDA (registration 3011301313) in San Antonio, TX, United States. It lists 29 device types. The FDA files 31 510(k) clearances under its listings, the newest dated November 18, 2025. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Nvision Biomedical Technologies, Inc
FDA registration number
3011301313
Address
12449 Silicon Dr, San Antonio, TX, United States, 78249
Owner or operator
Nvision Biomedical Technologies, Inc. (10048243)
Roles
Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
First device listed
December 19, 2014
Registered through
2026
Brand names listed
3D Printed PEEK Interbody System, Boundary, Caliber Intramedullary Fixation System, FOCUS Pedical Screw System, Focus, Focus Pedicle Screw System, Healix, Healix Compression Screw System and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Repackager or relabeler, Specification developeraccessdata.fda.gov
AwlHWJ1Repackager or relabeler, Specification developeraccessdata.fda.gov
BenderHXW1Repackager or relabeler, Specification developeraccessdata.fda.gov
Bit, DrillHTW1Repackager or relabeler, Specification developeraccessdata.fda.gov
Bone WedgePLF2Repackager or relabeler, Specification developeraccessdata.fda.gov
CountersinkHWW1Repackager or relabeler, Specification developeraccessdata.fda.gov
CuretteHTF1Repackager or relabeler, Specification developeraccessdata.fda.gov
Driver, Surgical, PinGFC1Repackager or relabeler, Specification developeraccessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft TissueMBI2Repackager or relabeler, Specification developeraccessdata.fda.gov
Fork, TuningGWX1Repackager or relabeler, Specification developeraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Repackager or relabeler, Specification developeraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Repackager or relabeler, Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Repackager or relabeler, Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Repackager or relabeler, Specification developeraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Repackager or relabeler, Specification developeraccessdata.fda.gov
Pin, Fixation, SmoothHTY2Repackager or relabeler, Specification developeraccessdata.fda.gov
Pin, Fixation, ThreadedJDW2Repackager or relabeler, Specification developeraccessdata.fda.gov
Plate, Fixation, BoneHRS2Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
ProbeHXB1Repackager or relabeler, Specification developeraccessdata.fda.gov
Punch, SurgicalLRY1Repackager or relabeler, Specification developeraccessdata.fda.gov
RaspHTR1Repackager or relabeler, Specification developeraccessdata.fda.gov
Screw, Fixation, BoneHWC2Repackager or relabeler, Specification developeraccessdata.fda.gov
ScrewdriverHXX1Repackager or relabeler, Specification developeraccessdata.fda.gov
Staple, Fixation, BoneJDR2Repackager or relabeler, Specification developeraccessdata.fda.gov
TampHXG1Repackager or relabeler, Specification developeraccessdata.fda.gov
Tap, BoneHWX1Repackager or relabeler, Specification developeraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Repackager or relabeler, Specification developeraccessdata.fda.gov
Tray, SurgicalLRP1Repackager or relabeler, Specification developeraccessdata.fda.gov
TrephineHWK1Repackager 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
November 18, 2025K253423ToeJack MIS Bunion SystemHRSSubstantially EquivalentNvision Biomedical Technologies, Inc.accessdata.fda.gov
June 11, 2025K250646Impact PEEK Union Nail SystemHTYSubstantially EquivalentNvision Biomedical Technologiesaccessdata.fda.gov
February 5, 2025K242896Caliber Intramedullary Fixation SystemHWCSubstantially EquivalentNvision Biomedical Technologiesaccessdata.fda.gov
November 8, 2024K243231Trigon PEEK HA WedgesPLFSubstantially EquivalentNvision Biomedical Technologiesaccessdata.fda.gov
September 17, 2024K2402503D Printed PEEK Interbody SystemMAXSubstantially EquivalentNvision Biomedical Technologies, Inc.accessdata.fda.gov
February 16, 2024K231453SnapHammer Hammertoe Correction SystemHWCSubstantially EquivalentNvision Biomedical Technologies, Inc.accessdata.fda.gov
January 26, 2024K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemPLFSubstantially EquivalentNvision Biomedical Technologiesaccessdata.fda.gov
July 5, 2023K222015Integral Titanium Cervical InterbodyODPSubstantially EquivalentNvision Biomedical Technologies, Inc.accessdata.fda.gov
December 1, 2022K223226Trigon™ HA Stand-Alone Wedge Fixation SystemPLFSubstantially EquivalentNvision Biomedical Technologies, Inc.accessdata.fda.gov
February 23, 2022K220197Trigon HA Wedge Fixation SystemPLFSubstantially EquivalentNvision Biomedical Technologies, Inc.accessdata.fda.gov
November 24, 2021K211650The Radian MIS Bunion SystemHRSSubstantially EquivalentNvision Biomedical Technologies, Inc.accessdata.fda.gov
November 19, 2021K213421Vector® Hammertoe Correction SystemHWCSubstantially EquivalentNvision Biomedical Technologies, Inc.accessdata.fda.gov
October 22, 2021K210424Quantum Anterior Cervical PlateKWQSubstantially EquivalentNvision Biomedical Technologies, Inc.accessdata.fda.gov
December 14, 2020K202657Javelin Tailor's Bunion Fixation SystemHRSSubstantially EquivalentNvision Biomedical Technologies, Inc.accessdata.fda.gov
November 10, 2020K200428Multi-Drive Interference Screw SystemMBISubstantially EquivalentNvision Biomedical Technologies, Inc.accessdata.fda.gov
August 4, 2020K201850Vector Hammertoe Correction SystemHWCSubstantially EquivalentNvision Biomedical Technologies, Inc.accessdata.fda.gov
May 5, 2020K200914Healix Compression Screw SystemHWCSubstantially EquivalentNvision Biomedical Technologies, Inc.accessdata.fda.gov
February 25, 2020K193414Trigon HA Stand-Alone Wedge Fixation SystemPLFSubstantially EquivalentNvision Biomedical Technologies, Inc.accessdata.fda.gov
January 13, 2020K193645nva, nvp, and nvtMAXSubstantially EquivalentNvision Biomedical Technologies, Inc.accessdata.fda.gov
December 23, 2019K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemPLFSubstantially EquivalentNvision Biomedical Technologies, Inc.accessdata.fda.gov
April 4, 2019K182943VERTEX Nitinol Staple SystemJDRSubstantially EquivalentNvision Biomedical Technologies, LLCaccessdata.fda.gov
March 21, 2019K190380nvcODPSubstantially EquivalentNvision Biomedical Technologies, Inc.accessdata.fda.gov
February 19, 2019K183055Vector Hammertoe Correction SystemHWCSubstantially EquivalentNvision Biomedical Technologies, LLCaccessdata.fda.gov
December 4, 2018K182949Healix™ Compression Screw SystemHWCSubstantially EquivalentNvision Biomedical Technologies, LLCaccessdata.fda.gov
April 17, 2018K180458FOCUS Pedicle Screw SystemNKBSubstantially EquivalentNvision Biomedical Technologies, LLCaccessdata.fda.gov
December 6, 2017K173091Boundary Anterior Lumbar Buttress PlateKWQSubstantially EquivalentNvision Biomedical Technologies, LLCaccessdata.fda.gov
January 24, 2017K170074nvcODPSubstantially EquivalentNvision Biomedical Technologies, LLCaccessdata.fda.gov
September 29, 2016K162426nva, nvp, and nvtMAXSubstantially EquivalentNvision Biomedical Technologies, LLCaccessdata.fda.gov
September 2, 2016K161524Tangis Anterior Cervical PlateKWQSubstantially EquivalentNvision Biomedical Technologies, LLCaccessdata.fda.gov
December 23, 2014K142328nvcODPSubstantially EquivalentNvision Biomedical Technologies, LLCaccessdata.fda.gov
November 28, 2014K142594nva, nvp, nvtMAXSubstantially EquivalentNvision Biomedical Technologies, LLCaccessdata.fda.gov

Compare with other makers

Updated November 18, 2025. 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.