510(k) Report

FDA applicant

Smv Scientific

Austin, TX5 decisions2015–20170 recalls

FDA records 5 decisions for Smv Scientific (Austin, TX) from 2015 to 2017: 5 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and HRS (Plate, Fixation, Bone). Since 2016 its 510(k)s took a median of 139 days from receipt to decision, against 131 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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 Smv Scientific’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2015: 22016: 22017: 1
2015high 2 (2015) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Smv Scientific by year, 2015–2026Sources: 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, Bone4decisions
  • HRSPlate, Fixation, Bone1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 139 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 131 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 14 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 0 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.

  • K170021SMV Scientific Cannulated ScrewsSmv Scientific · 20174cite it
  • K150981SMV Scientific Bone ScrewsSmv Scientific · 20152cite it
  • K152000SMV Scientific Bone Plate and Screw SystemSmv Scientific · 20152cite it
  • K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific · 20161cites it

What has FDA decided for it lately?

  • K170021SMV Scientific Cannulated ScrewsSmv Scientific · 2017
  • K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific · 2016
  • K160603SMV Scientific Schanz ScrewsSmv Scientific · 2016
  • K152000SMV Scientific Bone Plate and Screw SystemSmv Scientific · 2015
  • K150981SMV Scientific Bone ScrewsSmv Scientific · 2015

All 5 as Smv Scientific →