PAVLIK HARNESS

K780375 · Biomet, Inc. · IOZ · Mar 15, 1978 · Physical Medicine

Device Facts

Record IDK780375
Device NamePAVLIK HARNESS
ApplicantBiomet, Inc.
Product CodeIOZ · Physical Medicine
Decision DateMar 15, 1978
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 890.3665
Device ClassClass 1

Regulatory Classification

Identification

A congenital hip dislocation abduction splint is a device intended for medical purposes to stabilize the hips of a young child with dislocated hips in an abducted position (away from the midline).

Innolitics

Panel 1

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