510(k) Report

FDA applicant

Neucoll, Inc.

Los Gatos2 decisions1993–20010 recalls

FDA records 2 decisions for Neucoll, Inc. (Los Gatos) from 1993 to 2001: 1 510(k) clearance and 1 original PMA approval. Most are in product codes MBS (Filler, Bone Void, Non-Osteoinduction) and MQV (Filler, Bone Void, Calcium Compound). 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 Neucoll, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Neucoll, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Neucoll, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MBSFiller, Bone Void, Non-Osteoinduction1decision
  • MQVFiller, Bone Void, Calcium Compound1decision

Who builds on its devices?

Later devices cite its devices 7 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.

  • K000122Collagraft Strip Bone Graft Matrix (for Use as a Bone Filler), Model 1X,3X,6X (1,3 or 6 Strips Per Box)Neucoll, Inc. · 20017cite it

What has FDA decided for it lately?

  • K000122Collagraft Strip Bone Graft Matrix (for Use as a Bone Filler), Model 1X,3X,6X (1,3 or 6 Strips Per Box)Neucoll, Inc. · 2001
  • P900039Collagraft (TM) Bone Graft SubstituteNeucoll, Inc. · 1993

All 2 as Neucoll, Inc. →