Core Lumbar Fixation System

GUDID 00840967194530

TI STANDARD HIGH-TOP PEDICLE BOLT, 6.5MM X 45MM

ALPHATEC SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840967194530
• NIH Device Record Key: 8f666f53-1ed0-49a8-9b7e-cce2f3a47922
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Core Lumbar Fixation System
• Version Model Number: 81365-345
• Company DUNS: 602465783
• Company Name: ALPHATEC SPINE, INC.
• Device Count: 1
• DM Exempt: true
• 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

Customer Support Contacts

• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com

Device Dimensions

• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840967194530 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090228

FDA Product Code

• MNI: Orthosis, spinal pedicle fixation

Sterilization

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

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

[00840967194530]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-31
• Device Publish Date: 2020-07-23

On-Brand Devices [Core Lumbar Fixation System]

• 00844856045439: TI STANDARD HIGH-TOP PEDICLE BOLT - 7.5MM X 40MM
• 00844856045422: TI ELEVATED PEDICLE BOLT - 7.5mm X 40mm
• 00844856031548: ROC 2 SLOT PLATE
• 00844856021853: LARGE ROC ROD CONNECTOR, TI
• 00844856021846: SMALL ROC ROD CONNECTOR, TI
• 00844856021839: ROC NUT FULLY THREADED
• 00844856021822: ROC 3MM SPACER
• 00844856021808: ROC SLOTTED OFFSET LINK
• 00844856021730: ROC 4 SLOT PLATE 128mm
• 00844856021723: ROC 4 SLOT PLATE 114mm
• 00844856021693: ROC 3 SLOT PLATE 90mm
• 00844856021686: ROC 3 SLOT PLATE 76mm
• 00844856021679: ROC 3 SLOT PLATE 62mm
• 00844856021648: ROC 2 SLOT PLATE
• 00844856021624: 27MM 1 SINGLE SLOT PRE-CONTOURED PLATE
• 00844856021617: PRE-CONTOURED SINGLE SLOT 23MM PLATE , TI
• 00840967194875: TI STANDARD HIGH-TOP PEDICLE BOLT - 8.5MMX 40MM
• 00840967194868: TI STANDARD HIGH-TOP PEDICLE BOLT - 8.5MMX 35MM
• 00840967194813: TI ELEVATED HIGH -TOP PEDICLE BOLT- 7.5MM X 40MM
• 00840967194769: TI STANDARD HIGH-TOP PEDICLE BOLT - 7.5MM X 45MM
• 00840967194752: TI STANDARD HIGH-TOP PEDICLE BOLT - 7.5MM X 35MM
• 00840967194530: TI STANDARD HIGH-TOP PEDICLE BOLT, 6.5MM X 45MM
• 00840967194523: TI STANDARD HIGH-TOP PEDICLE BOLT, 6.5MM X 40MM
• 00840967194516: TI STANDARD HIGH-TOP PEDICLE BOLT, 6.5MM X 35MM
• 00840967194349: TI ELEVATED PEDICLE BOLT - 8.5mm X 40mm
• 00840967194301: TI STANDARD PEDICLE BOLT - 8.5mm X 80mm
• 00840967194295: TI STANDARD PEDICLE BOLT - 8.5mm X 65mm
• 00840967194288: TI STANDARD PEDICLE BOLT - 8.5mm X 50mm
• 00840967194271: TI STANDARD PEDICLE BOLT - 8.5mm X 45mm
• 00840967194257: TI STANDARD PEDICLE BOLT - 8.5mm X 35mm
• 00840967194219: TI ELEVATED PEDICLE BOLT - 7.5mm X 45mm
• 00840967194202: TI ELEVATED PEDICLE BOLT - 7.5mm X 35mm
• 00840967194141: TI STANDARD PEDICLE BOLT - 7.5mm X 45mm
• 00840967194134: TI STANDARD PEDICLE BOLT - 7.5mm X 40mm
• 00840967194127: TI STANDARD PEDICLE BOLT - 7.5mm X 35mm
• 00840967193960: TI ELEVATED PEDICLE BOLT - 6.5mm X 45mm
• 00840967193953: TI ELEVATED PEDICLE BOLT - 6.5mm X 40mm
• 00840967193946: TI ELEVATED PEDICLE BOLT - 6.5mm X 35mm
• 00840967193908: TI STANDARD PEDICLE BOLT - 6.5mm X 45mm
• 00840967193892: TI STANDARD PEDICLE BOLT - 6.5mm X 40mm
• 00840967193885: TI STANDARD PEDICLE BOLT - 6.5mm X 35mm
• 00840967193786: TI STANDARD PEDICLE BOLT - 5.5mm X 45mm
• 00840967193779: TI STANDARD PEDICLE BOLT - 5.5mm X 40mm
• 00840967193687: IN-SITU ROD COUPLER, TOP LOADING
• 00840967193656: 6.35mm ADJUSTABLE BRIDGE, 37mm - 45mm
• 00840967193649: 6.35mm ADJUSTABLE BRIDGE, 29mm - 39mm
• 00840967193632: 6.35mm ADJUSTABLE BRIDGE, 24mm - 30mm