Variable Angle Locking Peg

GUDID 00840118110037

implants for orthopedic bone fixation

FLOWER ORTHOPEDICS CORPORATION

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID00840118110037
NIH Device Record Key36e83208-0a64-4b4b-b00c-8804aea9b07e
Commercial Distribution StatusIn Commercial Distribution
Brand NameVariable Angle Locking Peg
Version Model NumberFLP 116
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

Device Dimensions

Outer Diameter1.8 Millimeter
Length16 Millimeter
Outer Diameter1.8 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840118110037 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-15

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