Cequence Anterior Cervical Plate 0254-0021

GUDID 00846468018337

CEQUENCE CONSTRAINED SINGLE BARREL DRILL GUIDE II

Pioneer Surgical Technology, Inc.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00846468018337
• NIH Device Record Key: cfa101cf-b017-4441-a4de-ce3859c960b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cequence Anterior Cervical Plate
• Version Model Number: 0254-0021
• Catalog Number: 0254-0021
• Company DUNS: 793384496
• Company Name: Pioneer Surgical Technology, Inc.
• 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
GS1	00846468018337 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081132

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[00846468018337]

Moist Heat or Steam Sterilization

[00846468018337]

Moist Heat or Steam Sterilization

[00846468018337]

Moist Heat or Steam Sterilization

[00846468018337]

Moist Heat or Steam Sterilization

[00846468018337]

Moist Heat or Steam Sterilization

[00846468018337]

Moist Heat or Steam Sterilization

[00846468018337]

Moist Heat or Steam Sterilization

[00846468018337]

Moist Heat or Steam Sterilization

[00846468018337]

Moist Heat or Steam Sterilization

[00846468018337]

Moist Heat or Steam Sterilization

[00846468018337]

Moist Heat or Steam Sterilization

[00846468018337]

Moist Heat or Steam Sterilization

[00846468018337]

Moist Heat or Steam Sterilization

[00846468018337]

Moist Heat or Steam Sterilization

[00846468018337]

Moist Heat or Steam Sterilization

[00846468018337]

Moist Heat or Steam Sterilization

[00846468018337]

Moist Heat or Steam Sterilization

[00846468018337]

Moist Heat or Steam Sterilization

[00846468018337]

Moist Heat or Steam Sterilization

[00846468018337]

Moist Heat or Steam Sterilization

[00846468018337]

Moist Heat or Steam Sterilization

[00846468018337]

Moist Heat or Steam Sterilization

[00846468018337]

Moist Heat or Steam Sterilization

[00846468018337]

Moist Heat or Steam Sterilization

[00846468018337]

Moist Heat or Steam Sterilization

[00846468018337]

Moist Heat or Steam Sterilization

[00846468018337]

Moist Heat or Steam Sterilization

[00846468018337]

Moist Heat or Steam Sterilization

[00846468018337]

Moist Heat or Steam Sterilization

[00846468018337]

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: 2016-06-10

On-Brand Devices [Cequence Anterior Cervical Plate]

• 00846468066529: CEQUENCE TEMPORARY FIXATION PIN FOR BONE SCREW
• 00846468048600: Norvill Self-Centering Bone Awl
• 00846468018580: CEQUENCE COUNTER TORQUE WRENCH II
• 00846468018573: TORQUE LIMITING HANDLE
• 00846468018566: CEQUENCE FIXED HANDLE SCREWDRIVER FOR DOUBLE BARREL DRILL GUIDE
• 00846468018542: CEQUENCE MODULAR SCREWDRIVER SHAFT II W/AO FITTING
• 00846468018535: Modular Screw Driver Shaft I w/AO Fitting
• 00846468018528: SMALL STRAIGHT MODULAR RATCHETING HANDLE W/AO FITTING
• 00846468018511: CEQUENCE MODULAR TAP II W/AO FITTING: 4.0MM
• 00846468018504: Modular Drill, 1.9mmØ, 18mm
• 00846468018498: Modular Drill, 1.9mmØ, 16mm
• 00846468018481: Modular Drill, 1.9mmØ, 14mm
• 00846468018474: Modular Drill, 1.9mmØ, 12mm
• 00846468018467: Modular Drill, 1.9mmØ, 10mm
• 00846468018450: CEQUENCE 2.5MM DIAMETER MODULAR DRILL II W/AO FITTING: 18MM
• 00846468018443: CEQUENCE 2.5MM DIAMETER MODULAR DRILL II W/AO FITTING: 16MM
• 00846468018436: CEQUENCE 2.5MM DIAMETER MODULAR DRILL II W/AO FITTING: 14MM
• 00846468018429: CEQUENCE 2.5MM DIAMETER MODULAR DRILL II W/AO FITTING: 12MM
• 00846468018412: 2.5mm Diameter Modular Drill w/AO Fitting: 18mm
• 00846468018405: 2.5mm Diameter Modular Drill w/AO Fitting: 16mm
• 00846468018399: 2.5mm Diameter Modular Drill w/AO Fitting: 14mm
• 00846468018382: 2.5mm Diameter Modular Drill w/AO Fitting: 12mm
• 00846468018375: 2.5mm Diameter Modular Drill w/AO Fitting: 10mm
• 00846468018368: CEQUENCE FIXED HANDLE BONE AWL FOR DOUBLE BARREL DRILL GUIDE
• 00846468018351: CEQUENCE END HOLES DOUBLE BARREL DRILL GUIDE W/ADJUSTABLE HANDLE
• 00846468018344: CEQUENCE MIDDLE HOLES DOUBLE BARREL DRILL GUIDE W/ADJUSTABLE HANDLE
• 00846468018337: CEQUENCE CONSTRAINED SINGLE BARREL DRILL GUIDE II
• 00846468018320: Semi-Constrained Single Barrel Drill Guide II
• 00846468018313: CEQUENCE TEMPORARY FIXATION PIN FOR BONE SCREW HOLE
• 00846468018306: CEQUENCE TEMPORARY FIXATION SCREW-PIN
• 00846468018290: CEQUENCE TEMPORARY FIXATION SCREW-PIN INSERTER / REMOVER
• 00846468018283: CEQUENCE CERVICAL PLATE HOLDER
• 00846468018276: CEQUENCE FRENCH PLATE BENDER
• 00846468018269: HYBRID PLATE, 3-LEVEL
• 00846468018252: HYBRID PLATE, 3-LEVEL
• 00846468018245: HYBRID PLATE, 3-LEVEL
• 00846468018238: HYBRID PLATE, 3-LEVEL
• 00846468018221: HYBRID PLATE, 3-LEVEL
• 00846468018214: HYBRID PLATE, 3-LEVEL
• 00846468018207: HYBRID PLATE, 3-LEVEL
• 00846468018191: HYBRID PLATE, 3-LEVEL
• 00846468018184: HYBRID PLATE, 3-LEVEL
• 00846468018177: HYBRID PLATE, 2-LEVEL
• 00846468018160: HYBRID PLATE, 2-LEVEL
• 00846468018153: HYBRID PLATE, 2-LEVEL
• 00846468018146: HYBRID PLATE, 2-LEVEL
• 00846468018139: HYBRID PLATE, 2-LEVEL
• 00846468018122: HYBRID PLATE, 2-LEVEL
• 00846468018115: HYBRID PLATE, 2-LEVEL
• 00846468018108: HYBRID PLATE, 2-LEVEL