510(k) Report

FDA applicant

Sanatmetal Mfr. of Orthopaedic/Traumatologic Prod.

Douglassville, PA1 decision2008–20080 recalls

FDA records 1 decision for Sanatmetal Mfr. of Orthopaedic/Traumatologic Prod. (Douglassville, PA) in 2008: 1 510(k) clearance. All are in product code HSB (Rod, Fixation, Intramedullary And Accessories). Its devices cite 5 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 Sanatmetal Mfr. of Orthopaedic/Traumatologic Prod.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Sanatmetal Mfr. of Orthopaedic/Traumatologic Prod. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HSBRod, Fixation, Intramedullary And Accessories1decision

Whose devices does it build on?

Its devices cite 5 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.

  • K070761Sanatmetal Nails and PinsSanatmetal Mfr. of Orthopaedic/Traumatologic Prod. · 20081cites it

What has FDA decided for it lately?

  • K070761Sanatmetal Nails and PinsSanatmetal Mfr. of Orthopaedic/Traumatologic Prod. · 2008

The one decision as Sanatmetal Mfr. of Orthopaedic/Traumatologic Prod. →