510(k) Report

FDA applicant

Nvision Biomedical Technologies, Inc.

San Antonio, TX40 decisions2014–20260 recalls

FDA records 40 decisions for Nvision Biomedical Technologies, Inc. (San Antonio, TX) from 2014 to 2026: 40 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and PLF (Bone Wedge). Since 2016 its 510(k)s took a median of 88 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 103 predicates, 37 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Nvision Biomedical Technologies, LLC”, “Nvision Biomedical Technologies”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Nvision Biomedical Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

5in 2025

2014: 22016: 22017: 22018: 22019: 42020: 72021: 32022: 32023: 22024: 42025: 52026 (partial year): 4
2014high 7 (2020) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Nvision Biomedical Technologies, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HWCScrew, Fixation, Bone9decisions
  • PLFBone Wedge7decisions
  • HRSPlate, Fixation, Bone6decisions
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar5decisions
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical4decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body3decisions

Also: HTY (2), ETN (1), JDR (1), NKB (1), MBI (1).

How long do its 510(k) reviews take?

Since 2016, its 33 510(k)s took a median of 88 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 14 of its 33 were faster than that.

Whose devices does it build on?

Its devices cite 103 predicates; 37 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 44 times; 37 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 20205cite it
  • K182949Healix™ Compression Screw SystemNvision Biomedical Technologies, LLC · 20184cite it
  • K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 20223cite it
  • K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc. · 20203cite it
  • K161524Tangis Anterior Cervical PlateNvision Biomedical Technologies, LLC · 20163cite it
  • K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc. · 20212cite it

What has FDA decided for it lately?

  • K261961Ntegrate Threaded Nail SystemNvision Biomedical Technologies · 2026
  • K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies · 2026
  • K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc. · 2026
  • K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc. · 2026
  • K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc. · 2025
  • K252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc. · 2025
  • K250646Impact PEEK Union Nail SystemNvision Biomedical Technologies · 2025
  • K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2025

All 24 as Nvision Biomedical Technologies, Inc. →All 10 as Nvision Biomedical Technologies, LLC →All 6 as Nvision Biomedical Technologies →

Other applicant names beginning “Nvision”

FDA records each applicant name separately; these may or may not be the same firm.

Nvision Medical Corporation 2