510(k) Report

FDA applicant

Summit Medventures

Austin, TX2 decisions2015–20180 recalls

FDA records 2 decisions for Summit Medventures (Austin, TX) from 2015 to 2018: 2 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and JDW (Pin, Fixation, Threaded). Its devices cite 2 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 Summit Medventures’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2015: 12018: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Summit Medventures 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, Bone1decision
  • JDWPin, Fixation, Threaded1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K182171SMV Scientific K-Wire and PinsSummit Medventures · 20181cites it

What has FDA decided for it lately?

  • K182171SMV Scientific K-Wire and PinsSummit Medventures · 2018
  • K150188SMV Scientific 4.5 mm Bone ScrewsSummit Medventures · 2015

All 2 as Summit Medventures →

Other applicant names beginning “Summit”

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

Summit Medical, Inc. 14Summit World Trade Corp. 10Summit Industries, Inc. 8Summit Doppler Systems, Inc. 7Summit Nuclear 6Summit Technology, Inc. 5Summit Glove, Inc. 5Summit Medical Products, Inc. 4Summit Optics, Inc. 2Summit Spine 2Summit Durable Medical Equipment, Inc. 1Summit TO Sea 1