FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET

Plate, Fixation, Bone

FLOWER ORTHOPEDICS CORPORATION

The following data is part of a premarket notification filed by Flower Orthopedics Corporation with the FDA for Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating Set.

Pre-market Notification Details

Device IDK133930
510k NumberK133930
Device Name:FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET
ClassificationPlate, Fixation, Bone
Applicant FLOWER ORTHOPEDICS CORPORATION 100 Witmer Rd Ste 280 Horsham,  PA  19044
ContactGary Barnett
CorrespondentGary Barnett
FLOWER ORTHOPEDICS CORPORATION 100 Witmer Rd Ste 280 Horsham,  PA  19044
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-23
Decision Date2014-03-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840118115797 K133930 000
00840118115650 K133930 000
00840118115667 K133930 000
00840118115674 K133930 000
00840118115681 K133930 000
00840118115698 K133930 000
00840118115742 K133930 000
00840118115759 K133930 000
00840118115766 K133930 000
00840118115773 K133930 000
00840118115780 K133930 000
00840118115643 K133930 000

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