Talon

GUDID 00840916110826

65mm Flex 5.5mm Pre-Bent Rod

SPINAL ELEMENTS

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00840916110826
NIH Device Record Key1b8603af-1c06-4873-8dde-b427804d0ec2
Commercial Distribution StatusIn Commercial Distribution
Brand NameTalon
Version Model NumberT80065-C
Company DUNS004022104
Company NameSPINAL ELEMENTS
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840916110826 [Primary]

FDA Product Code

MNHOrthosis, Spondylolisthesis Spinal Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840916110826]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-03-25
Device Publish Date2017-07-05

On-Brand Devices [Talon]

0084091613403710mm Talon Spacer
008409161340205mm Talon Spacer
008409161340133mm Talon Spacer
00840916135539LCT BULLET ROD INSERTER
008409161115957.0 x 55mm Lo-Top Talon Screw
008409161115887.0 x 50mm Lo-Top Talon Screw
008409161115717.0mm x 45mm Lo-Top Talon Screw
008409161115647.0mm x 40mm Lo-Top Talon Screw
008409161115577.0mm x 35mm Lo-Top Talon Screw
008409161115406.0mm x 55mm Lo-Top Talon Screw
008409161115266.0mm x 45mm Lo-Top Talon Screw
008409161115196.0mm x 40mm Lo-Top Talon Screw
008409161115026.0mm x 35mm Lo-Top Talon Screw
008409161114965.0mm x 50mm Lo-Top Talon Screw
008409161114655.0mm x 35mm Lo-Top Talon Screw
00840916110956100mm Flex 5.5mm Straight Rod
0084091611092590mm Flex 5.5mm Pre-Bent Rod
0084091611091890mm Flex 5.5mm Straight Rod
0084091611090185mm Flex 5.5mm Pre-Bent Rod
0084091611089585mm Flex 5.5mm Straight Rod
0084091611088880mm Flex 5.5mm Pre-Bent Rod
0084091611086475mm Flex 5.5mm Pre-Bent Rod
0084091611082665mm Flex 5.5mm Pre-Bent Rod
008409161099437.0mm x 40mm Reduction Tab Screw
008409161099367.0mm x 35mm Reduction Tab Screw
008409161116328.0 x 50mm Lo-Top Talon Screw
008409161116258.0mm x 45mm Lo-Top Talon Screw
008409161116188.0 x 40mm Lo-Top Talon Screw
008409161116018.0 x 35mm Lo-Top Talon Screw
008409161115336.0mm x 50mm Lo-Top Talon Screw
008409161111825.5mm x 150mm Pre-Bent Rod
008409161111755.5mm x 140mm Pre-Bent Rod
008409161111515.5mm x 120mm Pre-Bent Rod
008409161111445.5mm x 110mm Pre-Bent Rod
008409161111375.5mm x 100mm Pre-Bent Rod
008409161111205.5mm x 90mm Pre-Bent Rod
008409161111135.5mm x 80mm Pre-Bent Rod
008409161111065.5mm x 70mm Pre-Bent Rod
008409161110905.5mm x 60mm Pre-Bent Rod
008409161110835.5mm x 50mm Pre-Bent Rod
008409161110765.5mm X 45mm Pre-Bent Rod
008409161110695.5mm x 40mm Pre-Bent Rod
008409161110525.5mm x 35mm Prebent Rod
00840916111021Cross Link, Medium 45-60mm
00840916111014Cross Link, Small 35-45mm
00840916111007Cross Link, X-Small 27-35mm
00840916110499Flat Lock Screw
008409161104758.0mm x 60mm Lo-Top Talon Screw
008409161104688.0mm x 55mm Polyaxial Screw
008409161104518.0mm x 50mm Polyaxial Screw

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