PAC Plate Anterior Cervical Plate System 20-468-D

GUDID 00846468024338

FOUR LEVEL, DYNAMIC 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 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: 00846468024338
• NIH Device Record Key: 8ba48fd0-8a25-4df3-8a93-250947550fa4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PAC Plate Anterior Cervical Plate System
• Version Model Number: 20-468-D
• Catalog Number: 20-468-D
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846468004408 [Primary]
GS1	00846468024338 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083663

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

[00846468024338]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-30
• Device Publish Date: 2019-12-21

On-Brand Devices [PAC Plate Anterior Cervical Plate System]

• 00846468049294: GUIDED AWL, MODULAR
• 00846468024901: CERVICAL SCREW EXTRACTOR
• 00846468024840: CERVICAL TAP, MODULAR
• 00846468024833: CERVICAL TAP, FIXED
• 00846468024826: STANDARD PLATE CADDY
• 00846468024819: STANDARD DRILL GUIDE
• 00846468024802: SCREW PLATE CADDY
• 00846468024796: CERVICAL PLATE BENDER
• 00846468024758: CERVICAL PIN, TEMPORARY, PLATE HOLDING
• 00846468024734: CERVICAL MODULAR HANDLE
• 00846468024727: CERVICAL MODULAR HANDLE
• 00846468024710: MODULAR DRILL, 14mm
• 00846468024703: MODULAR DRILL, 10mm
• 00846468024697: MODULAR AWL, 14mm
• 00846468024680: MODULAR AWL, 10mm
• 00846468024673: CERVICAL PLATE HOLDER
• 00846468024666: SELF-GUIDED AWL
• 00846468024659: DRILL GUIDE CASE
• 00846468024628: FIXED STANDARD DOUBLE BARREL DRILL GUIDE
• 00846468024598: FIXED DYNAMIC DOUBLE BARREL DRILL GUIDE
• 00846468024581: STANDARD, PISTOL GRIP DRILL GUIDE
• 00846468024574: DYNAMIC , PISTOL GRIP DRILL GUIDE
• 00846468024567: DYNAMIC PLATE CADDY
• 00846468024550: DYNAMIC DRILL GUIDE
• 00846468024543: CERVICAL DRIVER, MODULAR
• 00846468024536: CERVICAL DRIVER
• 00846468024512: CERVICAL DRILL, MODULAR, DISPOSABLE
• 00846468024505: CERVICAL DRILL, MODULAR
• 00846468024475: CERVICAL DRILL, FIXED LENGTH
• 00846468024468: CERVICAL CASE
• 00846468024444: CERVICAL BONE AWL MODULAR
• 00846468024437: CERVICAL BONE AWL
• 00846468024420: FOUR LEVEL, STANDARD PLATE
• 00846468024413: FOUR LEVEL, DYNAMIC PLATE
• 00846468024406: FOUR LEVEL, STANDARD PLATE
• 00846468024390: FOUR LEVEL, DYNAMIC PLATE
• 00846468024383: FOUR LEVEL, STANDARD PLATE
• 00846468024376: FOUR LEVEL, DYNAMIC PLATE
• 00846468024369: FOUR LEVEL, STANDARD PLATE
• 00846468024352: FOUR LEVEL, DYNAMIC PLATE
• 00846468024345: FOUR LEVEL, STANDARD PLATE
• 00846468024338: FOUR LEVEL, DYNAMIC PLATE
• 00846468024321: FOUR LEVEL, STANDARD PLATE
• 00846468024314: FOUR LEVEL, DYNAMIC PLATE
• 00846468024307: FOUR LEVEL, STANDARD PLATE
• 00846468024291: FOUR LEVEL, DYNAMIC PLATE
• 00846468024284: CERVICAL SCREW, VARIABLE SELF-TAPPING
• 00846468024277: CERVICAL SCREW, VARIABLE SELF-TAPPING
• 00846468024260: CERVICAL SCREW, VARIABLE SELF-TAPPING
• 00846468024253: CERVICAL SCREW, VARIABLE SELF-TAPPING