SYNTHES (USA) ORIBITAL MESH 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) Oribital Mesh Plates.

Pre-market Notification Details

Device IDK001311
510k NumberK001311
Device Name:SYNTHES (USA) ORIBITAL MESH PLATES
ClassificationPlate, Fixation, Bone
Applicant SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
ContactBonnie J Smith
CorrespondentBonnie J Smith
SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-04-25
Decision Date2000-06-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H9804213040 K001311 000
H9804203030 K001311 000
H9804203040 K001311 000
H9804204010 K001311 000
H9804204020 K001311 000
H9804210480 K001311 000
H9804210490 K001311 000
H9804213020 K001311 000
H9804213030 K001311 000
H9804203020 K001311 000

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