Jones Screw, Short Threaded, D: 6.5mm x L:35mm

GUDID 00840118114943

implants for orthopedic bone fixation

FLOWER ORTHOPEDICS CORPORATION

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID00840118114943
NIH Device Record Keyc7d2b29b-d519-470f-bb22-2ae7e660fc0c
Commercial Distribution StatusIn Commercial Distribution
Brand NameJones Screw, Short Threaded, D: 6.5mm x L:35mm
Version Model NumberFJS 335
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

Device Dimensions

Outer Diameter6.5 Millimeter
Length35 Millimeter
Outer Diameter6.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840118114943 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-20
Device Publish Date2019-06-12

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00840118121675 - Flex-Thread2023-12-25 Drill Bit, 1.9mm
00840118121682 - Flex-Thread2023-12-25 Drill Bit, 2.5mm
00840118121705 - Flex-Thread2023-12-25 Drill Bit, 2.8mm

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