TSRH SACRAL SPINAL SCREW

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 Sacral Spinal Screw.

Pre-market Notification Details

Device IDK883783
510k NumberK883783
Device Name:TSRH SACRAL SPINAL SCREW
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 For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-09-06
Decision Date1989-04-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00673978039718 K883783 000
00673978039428 K883783 000
00673978039411 K883783 000
00673978039404 K883783 000
00673978039381 K883783 000
00673978039374 K883783 000
00673978039350 K883783 000
00673978039336 K883783 000

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