510(k) Report

FDA applicant

Innvotec Surgical, Inc.

Washington, DC2 decisions2009–20100 recalls

FDA records 2 decisions for Innvotec Surgical, Inc. (Washington, DC) from 2009 to 2010: 2 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and MQP (Spinal Vertebral Body Replacement Device). 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 Innvotec Surgical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2009: 12010: 1
2009high 1 (2009) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Innvotec Surgical, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Innvotec Surgical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar1decision
  • MQPSpinal Vertebral Body Replacement Device1decision

Who builds on its devices?

Later devices cite its devices 10 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.

  • K093669Sec Ibf CageInnvotec Surgical, Inc. · 20109cite it
  • K091743Sec VBRInnvotec Surgical, Inc. · 20091cites it

What has FDA decided for it lately?

  • K093669Sec Ibf CageInnvotec Surgical, Inc. · 2010
  • K091743Sec VBRInnvotec Surgical, Inc. · 2009

All 2 as Innvotec Surgical, Inc. →