TALKEETNA 5.5 Lumbar Pedicle Screw System

GUDID B644TPS155000

TALKEETNA Set Screw

AXIS360 SURGICAL, INCOPORATED

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: B644TPS155000
• NIH Device Record Key: 98f991c7-46ef-40f3-b237-510efcb845a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TALKEETNA 5.5 Lumbar Pedicle Screw System
• Version Model Number: TPS1-55-00
• Company DUNS: 081208474
• Company Name: AXIS360 SURGICAL, INCOPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B644TPS155000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180301

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[B644TPS155000]

Moist Heat or Steam Sterilization

[B644TPS155000]

Moist Heat or Steam Sterilization

[B644TPS155000]

Moist Heat or Steam Sterilization

[B644TPS155000]

Moist Heat or Steam Sterilization

[B644TPS155000]

Moist Heat or Steam Sterilization

[B644TPS155000]

Moist Heat or Steam Sterilization

[B644TPS155000]

Moist Heat or Steam Sterilization

[B644TPS155000]

Moist Heat or Steam Sterilization

[B644TPS155000]

Moist Heat or Steam Sterilization

[B644TPS155000]

Moist Heat or Steam Sterilization

[B644TPS155000]

Moist Heat or Steam Sterilization

[B644TPS155000]

Moist Heat or Steam Sterilization

[B644TPS155000]

Moist Heat or Steam Sterilization

[B644TPS155000]

Moist Heat or Steam Sterilization

[B644TPS155000]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-07-17
• Device Publish Date: 2018-09-01

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

• B644TPS155870800: TALKEETNA 5.5 Self-breaking Crosslink 70-80mm
• B644TPS155860700: TALKEETNA 5.5 Self-breaking Crosslink 60-70mm
• B644TPS155850600: TALKEETNA 5.5 Self-breaking Crosslink 50-60mm
• B644TPS155840500: TALKEETNA 5.5 Self-breaking Crosslink 40-50mm
• B644TPS155830400: TALKEETNA 5.5 Self-breaking Crosslink 30-40mm
• B644TPS155754740: TALKEETNA 5.5 360 Adjustable Crosslink 54-74mm
• B644TPS155745540: TALKEETNA 5.5 360 Adjustable Crosslink 45-54mm
• B644TPS155660800: TALKEETNA 5.5 Adjustable Crosslink 60-80mm
• B644TPS155650700: TALKEETNA 5.5 Adjustable Crosslink 50-70mm
• B644TPS155640600: TALKEETNA 5.5 Adjustable Crosslink 40-60mm
• B644TPS155630500: TALKEETNA 5.5 Adjustable Crosslink 30-50mm
• B644TPS155500260: TALKEETNA 5.5 Fixed Crosslink 26mm
• B644TPS155500220: TALKEETNA 5.5 Fixed Crosslink 22mm
• B644TPS155500200: TALKEETNA 5.5 Fixed Crosslink 20mm
• B644TPS155500160: TALKEETNA 5.5 Fixed Crosslink 16mm
• B644TPS155490600: TALKEETNA 5.5 Large Multi Axial Reduction Screw 9.0 x 60mm
• B644TPS155490550: TALKEETNA 5.5 Large Multi Axial Reduction Screw 9.0 x 55mm
• B644TPS155490500: TALKEETNA 5.5 Large Multi Axial Reduction Screw 9.0 x 50mm
• B644TPS155490450: TALKEETNA 5.5 Large Multi Axial Reduction Screw 9.0 x 45mm
• B644TPS155490400: TALKEETNA 5.5 Large Multi Axial Reduction Screw 9.0 x 40mm
• B644TPS155490350: TALKEETNA 5.5 Large Multi Axial Reduction Screw 9.0 x 35mm
• B644TPS155490300: TALKEETNA 5.5 Large Multi Axial Reduction Screw 9.0 x 30mm
• B644TPS155485600: TALKEETNA 5.5 Large Multi Axial Reduction Screw 8.5 x 60mm
• B644TPS155485550: TALKEETNA 5.5 Large Multi Axial Reduction Screw 8.5 x 55mm
• B644TPS155485500: TALKEETNA 5.5 Large Multi Axial Reduction Screw 8.5 x 50mm
• B644TPS155485450: TALKEETNA 5.5 Large Multi Axial Reduction Screw 8.5 x 45mm
• B644TPS155485400: TALKEETNA 5.5 Large Multi Axial Reduction Screw 8.5 x 40mm
• B644TPS155485350: TALKEETNA 5.5 Large Multi Axial Reduction Screw 8.5 x 35mm
• B644TPS155485300: TALKEETNA 5.5 Large Multi Axial Reduction Screw 8.5 x 30mm
• B644TPS155475600: TALKEETNA 5.5 Multi Axial Reduction Screw 7.5 x 60mm
• B644TPS155475550: TALKEETNA 5.5 Multi Axial Reduction Screw 7.5 x 55mm
• B644TPS155475500: TALKEETNA 5.5 Multi Axial Reduction Screw 7.5 x 50mm
• B644TPS155475450: TALKEETNA 5.5 Multi Axial Reduction Screw 7.5 x 45mm
• B644TPS155475400: TALKEETNA 5.5 Multi Axial Reduction Screw 7.5 x 40mm
• B644TPS155475350: TALKEETNA 5.5 Multi Axial Reduction Screw 7.5 x 35mm
• B644TPS155475300: TALKEETNA 5.5 Multi Axial Reduction Screw 7.5 x 30mm
• B644TPS155465600: TALKEETNA 5.5 Multi Axial Reduction Screw 6.5 x 60mm
• B644TPS155465550: TALKEETNA 5.5 Multi Axial Reduction Screw 6.5 x 55mm
• B644TPS155465500: TALKEETNA 5.5 Multi Axial Reduction Screw 6.5 x 50mm
• B644TPS155465450: TALKEETNA 5.5 Multi Axial Reduction Screw 6.5 x 45mm
• B644TPS155465400: TALKEETNA 5.5 Multi Axial Reduction Screw 6.5 x 40mm
• B644TPS155465350: TALKEETNA 5.5 Multi Axial Reduction Screw 6.5 x 35mm
• B644TPS155465300: TALKEETNA 5.5 Multi Axial Reduction Screw 6.5 x 30mm
• B644TPS155455600: TALKEETNA 5.5 Multi Axial Reduction Screw 5.5 x 60mm
• B644TPS155455550: TALKEETNA 5.5 Multi Axial Reduction Screw 5.5 x 55mm
• B644TPS155455500: TALKEETNA 5.5 Multi Axial Reduction Screw 5.5 x 50mm
• B644TPS155455450: TALKEETNA 5.5 Multi Axial Reduction Screw 5.5 x 45mm
• B644TPS155455400: TALKEETNA 5.5 Multi Axial Reduction Screw 5.5 x 40mm
• B644TPS155455350: TALKEETNA 5.5 Multi Axial Reduction Screw 5.5 x 35mm
• B644TPS155455300: TALKEETNA 5.5 Multi Axial Reduction Screw 5.5 x 30mm