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
1-12 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
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