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

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

23 devices
1-23 of 23
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 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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