Medical Device Manufacturer · US , San Antonio , TX

Nvision Biomedical Technologies, Inc. - FDA 510(k) Cleared Devices

24 submissions · 24 cleared · Since 2019

Recent clearances: enHAnce PEEK Bunion System, Vortex5 Tailor's Bunion Correction System, ToeJack MIS Bunion System

24
Total
24
Cleared
0
Denied

Nvision Biomedical Technologies, Inc. has 24 FDA 510(k) cleared orthopedic devices. Based in San Antonio, US.

Latest FDA clearance: Apr 2026. Active since 2019.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Nvision Biomedical Technologies, Watershed Idea Foundry and Watershed Ideas Foundry.

FDA 510(k) Regulatory Record - Nvision Biomedical Technologies, Inc.

24 devices
1-24 of 24
Cleared Apr 01, 2026
enHAnce PEEK Bunion System
K253718 · HRS
Orthopedic · 128d
Cleared Mar 25, 2026
Vortex5 Tailor's Bunion Correction System
K260291 · HRS
Orthopedic · 55d
Cleared Nov 18, 2025
ToeJack MIS Bunion System
K253423 · HRS
Orthopedic · 54d
Cleared Sep 19, 2025
Impact PEEK Union Nail System
K252657 · HTY
Orthopedic · 28d
Cleared Apr 02, 2025
SnapHammer Hammertoe Correction System
K250613 · HWC
Orthopedic · 33d
Cleared Sep 17, 2024
3D Printed PEEK Interbody System
K240250 · MAX
Orthopedic · 231d
Cleared Feb 16, 2024
SnapHammer Hammertoe Correction System
K231453 · HWC
Orthopedic · 274d
Cleared Oct 06, 2023
EARP Nerve Cuff Electrode
K230853 · ETN
Neurology · 192d
Cleared Jul 05, 2023
Integral Titanium Cervical Interbody
K222015 · ODP
Orthopedic · 362d
Cleared Dec 01, 2022
Trigon™ HA Stand-Alone Wedge Fixation System
K223226 · PLF
Orthopedic · 44d
Cleared Apr 28, 2022
EARP Interbody System
K212477 · MAX
Orthopedic · 262d
Cleared Feb 23, 2022
Trigon HA Wedge Fixation System
K220197 · PLF
Orthopedic · 30d
Cleared Nov 24, 2021
The Radian MIS Bunion System
K211650 · HRS
Orthopedic · 180d
Cleared Nov 19, 2021
Vector® Hammertoe Correction System
K213421 · HWC
Orthopedic · 30d
Cleared Oct 22, 2021
Quantum Anterior Cervical Plate
K210424 · KWQ
Orthopedic · 253d
Cleared Dec 21, 2020
Trigon HA Stand-Alone Wedge Fixation System
K203445 · PLF
Orthopedic · 28d
Cleared Dec 14, 2020
Javelin Tailor's Bunion Fixation System
K202657 · HRS
Orthopedic · 91d
Cleared Nov 10, 2020
Multi-Drive Interference Screw System
K200428 · MBI
Orthopedic · 263d
Cleared Aug 04, 2020
Vector Hammertoe Correction System
K201850 · HWC
Orthopedic · 29d
Cleared May 05, 2020
Healix Compression Screw System
K200914 · HWC
Orthopedic · 29d
Cleared Feb 25, 2020
Trigon HA Stand-Alone Wedge Fixation System
K193414 · PLF
Orthopedic · 78d
Cleared Jan 13, 2020
nva, nvp, and nvt
K193645 · MAX
Orthopedic · 14d
Cleared Dec 23, 2019
Trigon™ Ti Stand-Alone Wedge Fixation System
K192645 · PLF
Orthopedic · 90d
Cleared Mar 21, 2019
nvc
K190380 · ODP
Orthopedic · 30d
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