ZERO Profile Interlocking Cortex Screw, 3.5mm x 80mm, T15, Flex-Thread™

GUDID 00840118117098

Intramedullary fixation rod and accessories

FLOWER ORTHOPEDICS CORPORATION

General internal orthopaedic fixation system implantation kit
Primary Device ID00840118117098
NIH Device Record Key2e3d9083-e80f-495f-8a54-b2687eb30a7b
Commercial Distribution StatusIn Commercial Distribution
Brand NameZERO Profile Interlocking Cortex Screw, 3.5mm x 80mm, T15, Flex-Thread™
Version Model Number8525-80-S
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

Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com

Device Dimensions

Outer Diameter3.5 Millimeter
Length80 Millimeter
Outer Diameter3.5 Millimeter
Length80 Millimeter
Outer Diameter3.5 Millimeter
Length80 Millimeter
Outer Diameter3.5 Millimeter
Length80 Millimeter
Outer Diameter3.5 Millimeter
Length80 Millimeter
Outer Diameter3.5 Millimeter
Length80 Millimeter
Outer Diameter3.5 Millimeter
Length80 Millimeter
Outer Diameter3.5 Millimeter
Length80 Millimeter
Outer Diameter3.5 Millimeter
Length80 Millimeter
Outer Diameter3.5 Millimeter
Length80 Millimeter
Outer Diameter3.5 Millimeter
Length80 Millimeter
Outer Diameter3.5 Millimeter
Length80 Millimeter
Outer Diameter3.5 Millimeter
Length80 Millimeter
Outer Diameter3.5 Millimeter
Length80 Millimeter
Outer Diameter3.5 Millimeter
Length80 Millimeter
Outer Diameter3.5 Millimeter
Length80 Millimeter
Outer Diameter3.5 Millimeter
Length80 Millimeter
Outer Diameter3.5 Millimeter
Length80 Millimeter
Outer Diameter3.5 Millimeter
Length80 Millimeter
Outer Diameter3.5 Millimeter
Length80 Millimeter
Outer Diameter3.5 Millimeter
Length80 Millimeter
Outer Diameter3.5 Millimeter
Length80 Millimeter
Outer Diameter3.5 Millimeter
Length80 Millimeter
Outer Diameter3.5 Millimeter
Length80 Millimeter
Outer Diameter3.5 Millimeter
Length80 Millimeter
Outer Diameter3.5 Millimeter
Length80 Millimeter
Outer Diameter3.5 Millimeter
Length80 Millimeter
Outer Diameter3.5 Millimeter
Length80 Millimeter
Outer Diameter3.5 Millimeter
Length80 Millimeter
Outer Diameter3.5 Millimeter
Length80 Millimeter
Outer Diameter3.5 Millimeter
Length80 Millimeter
Outer Diameter3.5 Millimeter
Length80 Millimeter
Outer Diameter3.5 Millimeter
Length80 Millimeter
Outer Diameter3.5 Millimeter
Length80 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840118117098 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-29
Device Publish Date2021-03-19

Devices Manufactured by FLOWER ORTHOPEDICS CORPORATION

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00840118124539 - Flower Orthopedics2025-02-06 OsteoCoil Nitinol Compression System- 6.5mm x 105mm
00840118124690 - Flower Orthopedics2025-02-06 OsteoCoil Nitinol Compression System- 7.3mm x 60mm
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
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