Leucadia Pedicle Screw System

GUDID 00844856075061

POLYAXIAL REDUCTION SCREW, 5 x 35mm

ALPHATEC SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00844856075061
• NIH Device Record Key: 9bd38740-33b9-4b0d-bcf9-9042fea30ecd
• Commercial Distribution Discontinuation: 2017-11-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Leucadia Pedicle Screw System
• Version Model Number: LC-PR0535
• 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

Device Dimensions

• Length: 35 Millimeter
• Length: 35 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844856075061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110588

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

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

[00844856075061]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-24

On-Brand Devices [Leucadia Pedicle Screw System]

• 00844856076037: POLYAXIAL SCREW, 8mm x 90mm
• 00844856076020: POLYAXIAL SCREW, 8mm x 80mm
• 00844856076013: POLYAXIAL SCREW, 8mm x 70mm
• 00844856076006: POLYAXIAL SCREW, 8mm x 65mm
• 00844856075993: POLYAXIAL SCREW, 8mm x 60mm
• 00844856075986: POLYAXIAL SCREW, 8mm x 55mm
• 00844856075979: POLYAXIAL SCREW, 8mm x 50mm
• 00844856075962: POLYAXIAL SCREW, 8mm x 45mm
• 00844856075955: POLYAXIAL SCREW, 8mm x 40mm
• 00844856075948: POLYAXIAL SCREW, 8mm x 35mm
• 00844856075931: POLYAXIAL SCREW, 8mm x 30mm
• 00844856075924: POLYAXIAL SCREW, 8mm x 100mm
• 00844856075917: POLYAXIAL SCREW, 7mm x 90mm
• 00844856075900: POLYAXIAL SCREW, 7mm x 80mm
• 00844856075894: POLYAXIAL SCREW, 7mm x 70mm
• 00844856075887: POLYAXIAL SCREW, 7mm x 65mm
• 00844856075870: POLYAXIAL SCREW, 7mm x 60mm
• 00844856075863: POLYAXIAL SCREW, 7mm x 55mm
• 00844856075856: POLYAXIAL SCREW, 7mm x 50mm
• 00844856075849: POLYAXIAL SCREW, 7mm x 45mm
• 00844856075832: POLYAXIAL SCREW, 7mm x 40mm
• 00844856075825: POLYAXIAL SCREW, 7mm x 35mm
• 00844856075818: POLYAXIAL SCREW, 7mm x 30mm
• 00844856075801: POLYAXIAL SCREW, 7mm x 100mm
• 00844856075795: POLYAXIAL SCREW, 6mm x 65mm
• 00844856075788: POLYAXIAL SCREW, 6mm x 60mm
• 00844856075771: POLYAXIAL SCREW, 6mm x 55mm
• 00844856075764: POLYAXIAL SCREW, 6mm x 50mm
• 00844856075757: POLYAXIAL SCREW, 6mm x 45mm
• 00844856075740: POLYAXIAL SCREW, 6mm x 40mm
• 00844856075733: POLYAXIAL SCREW, 6mm x 35mm
• 00844856075726: POLYAXIAL SCREW, 6mm x 30mm
• 00844856075719: POLYAXIAL SCREW, 5mm x 65mm
• 00844856075702: POLYAXIAL SCREW, 5mm x 60mm
• 00844856075696: POLYAXIAL SCREW, 5mm x 55mm
• 00844856075689: POLYAXIAL SCREW, 5mm x 50mm
• 00844856075672: POLYAXIAL SCREW, 5mm x 45mm
• 00844856075665: POLYAXIAL SCREW, 5mm x 40mm
• 00844856075658: POLYAXIAL SCREW, 5mm x 35mm
• 00844856075641: POLYAXIAL SCREW, 5mm x 30mm
• 00844856075634: 4.5 X 55MM, POLYAXIAL SCREW
• 00844856075627: 4.5 X 50MM, POLYAXIAL SCREW
• 00844856075610: 4.5 X 45MM, POLYAXIAL SCREW
• 00844856075603: 4.5 X 40MM, POLYAXIAL SCREW
• 00844856075597: 4.5 X 35MM, POLYAXIAL SCREW
• 00844856075580: 4.5 X 30MM, POLYAXIAL SCREW
• 00844856075573: 4.5 X 25MM, POLYAXIAL SCREW
• 00844856075443: POLYAXIAL REDUCTION SCREW, 8 x 90mm
• 00844856075436: POLYAXIAL REDUCTION SCREW, 8 x 80mm
• 00844856075429: POLYAXIAL REDUCTION SCREW, 8 x 70mm