SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES

Plate, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Lcp Proximal Femur Hook Plates.

Pre-market Notification Details

Device IDK032032
510k NumberK032032
Device Name:SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES
ClassificationPlate, Fixation, Bone
Applicant SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli,  PA  19301
ContactLisa M Boyle
CorrespondentLisa M Boyle
SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli,  PA  19301
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-07-01
Decision Date2003-09-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H679242128S0 K032032 000
H679242120S0 K032032 000
H6792421210 K032032 000
H679242121S0 K032032 000
H6792421220 K032032 000
H679242122S0 K032032 000
H6792421230 K032032 000
H679242123S0 K032032 000
H6792421240 K032032 000
H679242124S0 K032032 000
H6792421250 K032032 000
H679242125S0 K032032 000
H6792421260 K032032 000
H679242126S0 K032032 000
H6792421270 K032032 000
H679242127S0 K032032 000
H6792421280 K032032 000
H6792421200 K032032 000

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