FDA 510(k) clearance · back to tracker

ARCOS INTERLOCKING DISTAL STEMS

Biomet Manufacturing Corp cleared K100469 on 2010-12-07, decision: substantially equivalent

K-number

K100469

Sponsor

Biomet Manufacturing Corp

Device

ARCOS INTERLOCKING DISTAL STEMS

Class

Class III

Decision

Substantially Equivalent

Decision date

2010-12-07

Product code

KWA

Advisory committee

Orthopedic

Medical specialty

Orthopedic

Regulation number

888.3330

Official FDA record

Open K100469on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.