ASPECT Anterior Cervical Plate System 27-244

GUDID 00846468050924

TWO LEVEL, STANDARD PLATE

Pioneer Surgical Technology, Inc.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00846468050924
• NIH Device Record Key: f4971564-9a45-4785-ab90-9e4255612e10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASPECT Anterior Cervical Plate System
• Version Model Number: 27-244
• Catalog Number: 27-244
• 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

Customer Support Contacts

• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00846468050924 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130427

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

[00846468050924]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-05
• Device Publish Date: 2020-09-25

On-Brand Devices [ASPECT Anterior Cervical Plate System]

• 00846468051532: FIVE LEVEL, STANDARD PLATE, 95mm
• 00846468051525: FIVE LEVEL, STANDARD PLATE, 90mm
• 00846468051518: FIVE LEVEL, STANDARD PLATE, 85mm
• 00846468051501: FIVE LEVEL, STANDARD PLATE, 80mm
• 00846468051495: FIVE LEVEL, STANDARD PLATE, 75mm
• 00846468051488: FIVE LEVEL, STANDARD PLATE, 105mm
• 00846468051471: FIVE LEVEL, STANDARD PLATE, 100mm
• 00846468084400: ASPECT CASE ASSY, 5 LEVEL, EMPTY
• 00846468061944: FIXED GUIDE, DTS, 18°
• 00846468061937: FIXED GUIDE, DTS, 9°
• 00846468061920: FIXED GUIDE, DTS, 0°
• 00846468052997: MODULAR TAP
• 00846468052980: MODULAR TAP
• 00846468052966: MODULAR TAP
• 00846468052942: MODULAR TAP
• 00846468052935: MODULAR DRILL
• 00846468052928: MODULAR DRILL
• 00846468052881: MODULAR DRILL
• 00846468051655: TEMPORARY PLATE HOLDING THREADED PIN
• 00846468051594: BONE AWL
• 00846468051587: BONE AWL
• 00846468051563: BONE AWL
• 00846468051556: BONE AWL
• 00846468051549: BONE AWL
• 00846468051464: FOUR LEVEL, STANDARD PLATE
• 00846468051457: FOUR LEVEL, STANDARD PLATE
• 00846468051389: VARIABLE SELF TAPPING RESCUE SCREW
• 00846468051372: VARIABLE SELF TAPPING RESCUE SCREW
• 00846468051334: VARIABLE SELF TAPPING RESCUE SCREW
• 00846468051327: FIXED SELF TAPPING RESCUE SCREW
• 00846468051310: FIXED SELF TAPPING RESCUE SCREW
• 00846468051273: FIXED SELF TAPPING RESCUE SCREW
• 00846468051266: VARIABLE SELF TAPPING SCREW
• 00846468051211: VARIABLE SELF TAPPING SCREW
• 00846468051204: VARIABLE SELF DRILLING SCREW
• 00846468051198: VARIABLE SELF DRILLING SCREW
• 00846468051150: VARIABLE SELF DRILLING SCREW
• 00846468051143: FIXED SELF TAPPING SCREW
• 00846468051099: FIXED SELF TAPPING SCREW
• 00846468051082: FIXED SELF DRILLING SCREW
• 00846468051075: FIXED SELF DRILLING SCREW
• 00846468051037: FIXED SELF DRILLING SCREW
• 00846468051020: THREE LEVEL, STANDARD PLATE
• 00846468051013: THREE LEVEL, STANDARD PLATE
• 00846468050924: TWO LEVEL, STANDARD PLATE
• 00846468050832: ONE LEVEL, STANDARD PLATE
• 00846468050825: ONE LEVEL, STANDARD PLATE