SYNTHES SACRAL BAR SYSTEM

Pin, Fixation, Threaded

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Sacral Bar System.

Pre-market Notification Details

Device IDK001720
510k NumberK001720
Device Name:SYNTHES SACRAL BAR SYSTEM
ClassificationPin, Fixation, Threaded
Applicant SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
ContactAngela J Silvestri
CorrespondentAngela J Silvestri
SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
Product CodeJDW  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-06-06
Decision Date2000-08-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H6792967590 K001720 000
H6792967580 K001720 000
H6792967570 K001720 000
H981SD4960020 K001720 000
H981SD4960010 K001720 000
H6792967660 K001720 000
H6792967630 K001720 000
H679199936S0 K001720 000
H679199933S0 K001720 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.