MICRO OSTEOSYNTHESIS SYSTEM (1.0)

K944561 · KLS-Martin L.P. · JEY · Oct 18, 1994 · Dental

Device Facts

Record IDK944561
Device NameMICRO OSTEOSYNTHESIS SYSTEM (1.0)
ApplicantKLS-Martin L.P.
Product CodeJEY · Dental
Decision DateOct 18, 1994
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.4760
Device ClassClass 2

Regulatory Classification

Identification

A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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