TSRH H/M HOOK HOLDER W/ROD MOVER

Appliance, Fixation, Spinal Interlaminal

WARSAW ORTHOPEDIC, INC.

The following data is part of a premarket notification filed by Warsaw Orthopedic, Inc. with the FDA for Tsrh H/m Hook Holder W/rod Mover.

Pre-market Notification Details

Device IDK880212
510k NumberK880212
Device Name:TSRH H/M HOOK HOLDER W/ROD MOVER
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant WARSAW ORTHOPEDIC, INC. P.O. BOX 1157 Warsaw,  IN  46580
ContactJames Ritter
CorrespondentJames Ritter
WARSAW ORTHOPEDIC, INC. P.O. BOX 1157 Warsaw,  IN  46580
Product CodeKWP  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-01-19
Decision Date1988-03-04

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