ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW

Screw, Fixation, Bone

SMITH AND NEPHEW DONJOY, INC.

The following data is part of a premarket notification filed by Smith And Nephew Donjoy, Inc. with the FDA for Rounded Cannulated Inside-out (rci) Acl Screw.

Pre-market Notification Details

Device IDK932862
510k NumberK932862
Device Name:ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW
ClassificationScrew, Fixation, Bone
Applicant SMITH AND NEPHEW DONJOY, INC. 2777 LOKER AVENUE WEST Carsbad,  CA  92008 -6601
ContactDan Miller
CorrespondentDan Miller
SMITH AND NEPHEW DONJOY, INC. 2777 LOKER AVENUE WEST Carsbad,  CA  92008 -6601
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-06-11
Decision Date1994-03-10

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