2.0mm Recon Plate, 14 Holes, 1.5mm/2.0mm/2.4mm

GUDID 00840118102803

implants for orthopedic bone fixation

FLOWER ORTHOPEDICS CORPORATION

Orthopaedic fixation plate, non-bioabsorbable, sterile
Primary Device ID00840118102803
NIH Device Record Key10fe9325-f356-4d04-a4ca-2ee0eaa90846
Commercial Distribution StatusIn Commercial Distribution
Brand Name2.0mm Recon Plate, 14 Holes, 1.5mm/2.0mm/2.4mm
Version Model NumberFHF 914
Company DUNS078790947
Company NameFLOWER ORTHOPEDICS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com

Device Dimensions

Height1.5 Millimeter
Height1.5 Millimeter
Height1.5 Millimeter
Height1.5 Millimeter
Height1.5 Millimeter
Height1.5 Millimeter
Height1.5 Millimeter
Height1.5 Millimeter
Height1.5 Millimeter
Height1.5 Millimeter
Height1.5 Millimeter
Height1.5 Millimeter
Height1.5 Millimeter
Height1.5 Millimeter
Height1.5 Millimeter
Height1.5 Millimeter
Height1.5 Millimeter
Height1.5 Millimeter
Height1.5 Millimeter
Height1.5 Millimeter
Height1.5 Millimeter
Height1.5 Millimeter
Height1.5 Millimeter
Height1.5 Millimeter
Height1.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840118102803 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-06-04

Devices Manufactured by FLOWER ORTHOPEDICS CORPORATION

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00840118124089 - Flower Orthopedics2025-02-05 OsteoCoil Nitinol Compression System- 4.5mm x 30mm
00840118124126 - Flower Orthopedics2025-02-05 OsteoCoil Nitinol Compression System- 4.5mm x 50mm
00840118124140 - Flower Orthopedics2025-02-05 OsteoCoil Nitinol Compression System- 4.5mm x 60mm
00840118124188 - Flower Orthopedics2025-02-05 OsteoCoil Nitinol Compression System- 4.5mm x 80mm
00840118124195 - Flower Orthopedics2025-02-05 OsteoCoil Nitinol Compression System- 4.5mm x 85mm

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