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Bard Permafix Fixation System (0113012 +3 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K092483

by C. R. Bard, Inc.

Identifiers

510(k) Number
K092483 FDA 510(k)
FDA Product Code
GDW FDA 510(k)
Models / Variants
0113012 FDA 510(k)
0113014 FDA 510(k)
0113016 FDA 510(k)
0116018 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4750 FDA 510(k)
Regulation Number
878.4750 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Bard Permafix Fixation System (0113012 +3 more) by C. R. Bard, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 4 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
C. R. Bard, Inc.
FDA Applicant
C.R. Bard, Inc.

Sources (1)

  • FDA 510(k) K092483 24 fields · synced Jun 18, 2026