510(k) Report

FDA applicant

Summit Spine

Georgetown, TX2 decisions2017–20170 recalls

FDA records 2 decisions for Summit Spine (Georgetown, TX) in 2017: 2 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and ODP (Intervertebral Fusion Device With Bone Graft…). Its devices cite 1 predicate, 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 Spine’s devices, and how often a recall has named them.

FDA decisions per year

2in 2017

2017: 2
2017high 2 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Summit Spine by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar1decision
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K170572Summit Spine Yellowstone Lumbar Interbody Fusion SystemSummit Spine · 20171cites it
  • K163494Summit Spine Channel Cervical Interbody Fusion SystemSummit Spine · 20171cites it

What has FDA decided for it lately?

  • K163494Summit Spine Channel Cervical Interbody Fusion SystemSummit Spine · 2017
  • K170572Summit Spine Yellowstone Lumbar Interbody Fusion SystemSummit Spine · 2017

All 2 as Summit Spine →

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 Medventures 2Summit Durable Medical Equipment, Inc. 1Summit TO Sea 1