SPECIALIST(R) WALKER

Splint, Extremity, Noninflatable, External, Sterile

JOHNSON & JOHNSON ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Johnson & Johnson Orthopaedics, Inc. with the FDA for Specialist(r) Walker.

Pre-market Notification Details

Device IDK924984
510k NumberK924984
Device Name:SPECIALIST(R) WALKER
ClassificationSplint, Extremity, Noninflatable, External, Sterile
Applicant JOHNSON & JOHNSON ORTHOPAEDICS, INC. Raynham,  MA  02767
ContactMarsha J Stone
CorrespondentMarsha J Stone
JOHNSON & JOHNSON ORTHOPAEDICS, INC. Raynham,  MA  02767
Product CodeFYH  
CFR Regulation Number878.3910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-10-01
Decision Date1993-02-01

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