SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Large Fragment Locking Compression Plate (lcp) System-t Plate.

Pre-market Notification Details

Device IDK010766
510k NumberK010766
Device Name:SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactBonnie Smith
CorrespondentBonnie Smith
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-03-14
Decision Date2001-06-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H6792401810 K010766 000
H6792401610 K010766 000
H6792401410 K010766 000
H6794401810 K010766 000
H6794401610 K010766 000
H6794401410 K010766 000

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