TALKEETNA 5.5 Lumbar Pedicle Screw System

GUDID B644TPS155365550

TALKEETNA 5.5 Multi Axial Screw 6.5 x 55mm

AXIS360 SURGICAL, INCOPORATED

Bone-screw internal spinal fixation system, non-sterile
Primary Device IDB644TPS155365550
NIH Device Record Keyb566d4cb-6755-4a92-a26b-073b16bb6aa8
Commercial Distribution StatusIn Commercial Distribution
Brand NameTALKEETNA 5.5 Lumbar Pedicle Screw System
Version Model NumberTPS1-55-36555
Company DUNS081208474
Company NameAXIS360 SURGICAL, INCOPORATED
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
HIBCCB644TPS155365550 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B644TPS155365550]

Moist Heat or Steam Sterilization


[B644TPS155365550]

Moist Heat or Steam Sterilization


[B644TPS155365550]

Moist Heat or Steam Sterilization


[B644TPS155365550]

Moist Heat or Steam Sterilization


[B644TPS155365550]

Moist Heat or Steam Sterilization


[B644TPS155365550]

Moist Heat or Steam Sterilization


[B644TPS155365550]

Moist Heat or Steam Sterilization


[B644TPS155365550]

Moist Heat or Steam Sterilization


[B644TPS155365550]

Moist Heat or Steam Sterilization


[B644TPS155365550]

Moist Heat or Steam Sterilization


[B644TPS155365550]

Moist Heat or Steam Sterilization


[B644TPS155365550]

Moist Heat or Steam Sterilization


[B644TPS155365550]

Moist Heat or Steam Sterilization


[B644TPS155365550]

Moist Heat or Steam Sterilization


[B644TPS155365550]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-07-17
Device Publish Date2018-09-01

On-Brand Devices [TALKEETNA 5.5 Lumbar Pedicle Screw System]

B644TPS155870800TALKEETNA 5.5 Self-breaking Crosslink 70-80mm
B644TPS155860700TALKEETNA 5.5 Self-breaking Crosslink 60-70mm
B644TPS155850600TALKEETNA 5.5 Self-breaking Crosslink 50-60mm
B644TPS155840500TALKEETNA 5.5 Self-breaking Crosslink 40-50mm
B644TPS155830400TALKEETNA 5.5 Self-breaking Crosslink 30-40mm
B644TPS155754740TALKEETNA 5.5 360 Adjustable Crosslink 54-74mm
B644TPS155745540TALKEETNA 5.5 360 Adjustable Crosslink 45-54mm
B644TPS155660800TALKEETNA 5.5 Adjustable Crosslink 60-80mm
B644TPS155650700TALKEETNA 5.5 Adjustable Crosslink 50-70mm
B644TPS155640600TALKEETNA 5.5 Adjustable Crosslink 40-60mm
B644TPS155630500TALKEETNA 5.5 Adjustable Crosslink 30-50mm
B644TPS155500260TALKEETNA 5.5 Fixed Crosslink 26mm
B644TPS155500220TALKEETNA 5.5 Fixed Crosslink 22mm
B644TPS155500200TALKEETNA 5.5 Fixed Crosslink 20mm
B644TPS155500160TALKEETNA 5.5 Fixed Crosslink 16mm
B644TPS155490600TALKEETNA 5.5 Large Multi Axial Reduction Screw 9.0 x 60mm
B644TPS155490550TALKEETNA 5.5 Large Multi Axial Reduction Screw 9.0 x 55mm
B644TPS155490500TALKEETNA 5.5 Large Multi Axial Reduction Screw 9.0 x 50mm
B644TPS155490450TALKEETNA 5.5 Large Multi Axial Reduction Screw 9.0 x 45mm
B644TPS155490400TALKEETNA 5.5 Large Multi Axial Reduction Screw 9.0 x 40mm
B644TPS155490350TALKEETNA 5.5 Large Multi Axial Reduction Screw 9.0 x 35mm
B644TPS155490300TALKEETNA 5.5 Large Multi Axial Reduction Screw 9.0 x 30mm
B644TPS155485600TALKEETNA 5.5 Large Multi Axial Reduction Screw 8.5 x 60mm
B644TPS155485550TALKEETNA 5.5 Large Multi Axial Reduction Screw 8.5 x 55mm
B644TPS155485500TALKEETNA 5.5 Large Multi Axial Reduction Screw 8.5 x 50mm
B644TPS155485450TALKEETNA 5.5 Large Multi Axial Reduction Screw 8.5 x 45mm
B644TPS155485400TALKEETNA 5.5 Large Multi Axial Reduction Screw 8.5 x 40mm
B644TPS155485350TALKEETNA 5.5 Large Multi Axial Reduction Screw 8.5 x 35mm
B644TPS155485300TALKEETNA 5.5 Large Multi Axial Reduction Screw 8.5 x 30mm
B644TPS155475600TALKEETNA 5.5 Multi Axial Reduction Screw 7.5 x 60mm
B644TPS155475550TALKEETNA 5.5 Multi Axial Reduction Screw 7.5 x 55mm
B644TPS155475500TALKEETNA 5.5 Multi Axial Reduction Screw 7.5 x 50mm
B644TPS155475450TALKEETNA 5.5 Multi Axial Reduction Screw 7.5 x 45mm
B644TPS155475400TALKEETNA 5.5 Multi Axial Reduction Screw 7.5 x 40mm
B644TPS155475350TALKEETNA 5.5 Multi Axial Reduction Screw 7.5 x 35mm
B644TPS155475300TALKEETNA 5.5 Multi Axial Reduction Screw 7.5 x 30mm
B644TPS155465600TALKEETNA 5.5 Multi Axial Reduction Screw 6.5 x 60mm
B644TPS155465550TALKEETNA 5.5 Multi Axial Reduction Screw 6.5 x 55mm
B644TPS155465500TALKEETNA 5.5 Multi Axial Reduction Screw 6.5 x 50mm
B644TPS155465450TALKEETNA 5.5 Multi Axial Reduction Screw 6.5 x 45mm
B644TPS155465400TALKEETNA 5.5 Multi Axial Reduction Screw 6.5 x 40mm
B644TPS155465350TALKEETNA 5.5 Multi Axial Reduction Screw 6.5 x 35mm
B644TPS155465300TALKEETNA 5.5 Multi Axial Reduction Screw 6.5 x 30mm
B644TPS155455600TALKEETNA 5.5 Multi Axial Reduction Screw 5.5 x 60mm
B644TPS155455550TALKEETNA 5.5 Multi Axial Reduction Screw 5.5 x 55mm
B644TPS155455500TALKEETNA 5.5 Multi Axial Reduction Screw 5.5 x 50mm
B644TPS155455450TALKEETNA 5.5 Multi Axial Reduction Screw 5.5 x 45mm
B644TPS155455400TALKEETNA 5.5 Multi Axial Reduction Screw 5.5 x 40mm
B644TPS155455350TALKEETNA 5.5 Multi Axial Reduction Screw 5.5 x 35mm
B644TPS155455300TALKEETNA 5.5 Multi Axial Reduction Screw 5.5 x 30mm

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