SLIMFUSE ANTERIOR CERVICAL PLATE SYSTEM 21-366-D

GUDID 00846468092382

THREE 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

• Primary Device ID: 00846468092382
• NIH Device Record Key: daa5c60f-6c0d-4c6e-b39d-a784ee369a06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SLIMFUSE ANTERIOR CERVICAL PLATE SYSTEM
• Version Model Number: 21-366-D
• Catalog Number: 21-366-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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846468092382 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072703

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[00846468092382]

Moist Heat or Steam Sterilization

[00846468092382]

Moist Heat or Steam Sterilization

[00846468092382]

Moist Heat or Steam Sterilization

[00846468092382]

Moist Heat or Steam Sterilization

[00846468092382]

Moist Heat or Steam Sterilization

[00846468092382]

Moist Heat or Steam Sterilization

[00846468092382]

Moist Heat or Steam Sterilization

[00846468092382]

Moist Heat or Steam Sterilization

[00846468092382]

Moist Heat or Steam Sterilization

[00846468092382]

Moist Heat or Steam Sterilization

[00846468092382]

Moist Heat or Steam Sterilization

[00846468092382]

Moist Heat or Steam Sterilization

[00846468092382]

Moist Heat or Steam Sterilization

[00846468092382]

Moist Heat or Steam Sterilization

[00846468092382]

Moist Heat or Steam Sterilization

[00846468092382]

Moist Heat or Steam Sterilization

[00846468092382]

Moist Heat or Steam Sterilization

[00846468092382]

Moist Heat or Steam Sterilization

[00846468092382]

Moist Heat or Steam Sterilization

[00846468092382]

Moist Heat or Steam Sterilization

[00846468092382]

Moist Heat or Steam Sterilization

[00846468092382]

Moist Heat or Steam Sterilization

[00846468092382]

Moist Heat or Steam Sterilization

[00846468092382]

Moist Heat or Steam Sterilization

[00846468092382]

Moist Heat or Steam Sterilization

[00846468092382]

Moist Heat or Steam Sterilization

[00846468092382]

Moist Heat or Steam Sterilization

[00846468092382]

Moist Heat or Steam Sterilization

[00846468092382]

Moist Heat or Steam Sterilization

[00846468092382]

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 [SLIMFUSE ANTERIOR CERVICAL PLATE SYSTEM]

• 00846468062682: Final Driver, Extended
• 00846468062675: Screw Inserter, Cannulated
• 00846468050580: Disposable Torque-Limiting Final Driver
• 00846468049317: HOLDING PIN INSERTER, MODULAR
• 00846468025960: DRIVER, TORQUE LIMITING
• 00846468025946: STANDARD PLATE CADDY
• 00846468025939: SCREW PLATE CADDY
• 00846468025922: PLATE HOLDER
• 00846468025915: PLATE BENDER
• 00846468025908: TEMPORARY HOLDING PIN INSERTER/EXTRACTOR
• 00846468025892: TEMPORARY HOLDING PIN
• 00846468025885: MODULAR TAP
• 00846468025878: MODULAR DRILL
• 00846468025861: MODULAR DRILL
• 00846468025854: MODULAR BONE AWL
• 00846468025847: MODULAR BONE AWL
• 00846468025830: GUIDE
• 00846468025823: INSTRUMENT CASE
• 00846468025816: INSTRUMENT, GUIDE SLEEVE
• 00846468025809: INSTRUMENT, HANDLED GUIDE
• 00846468025793: SCREW DRIVER, INTERNAL SET SCREW
• 00846468025786: SCREW DRIVER, INTERNAL SET SCREW
• 00846468025779: FIXED HANDLED TAP
• 00846468025762: FIXED HANDLED TAP
• 00846468025755: FIXED HANDLED DRILL
• 00846468025748: FIXED HANDLED DRILL
• 00846468025731: FIXED HANDLED BONE AWL
• 00846468025724: FIXED HANDLED BONE AWL
• 00846468025717: DYNAMIC PLATE CADDY
• 00846468025700: SCREW DRIVER, BONE SCREW
• 00846468025694: SCREW DRIVER, BONE SCREW
• 00846468025687: COUNTER TORQUE INSTRUMENT
• 00846468025670: CALIPER
• 00846468025632: DYNAMIC PLATE CADDY
• 00846468025304: DYNAMIC PLATE CADDY
• 00846468092603: SELF-DRILLING SCREW
• 00846468092443: FOUR LEVEL, DYNAMIC PLATE
• 00846468092436: FOUR LEVEL, DYNAMIC PLATE
• 00846468092429: FOUR LEVEL, DYNAMIC PLATE
• 00846468092412: FOUR LEVEL, DYNAMIC PLATE
• 00846468092405: FOUR LEVEL, DYNAMIC PLATE
• 00846468092399: FOUR LEVEL, DYNAMIC PLATE
• 00846468092382: THREE LEVEL, DYNAMIC PLATE
• 00846468092375: THREE LEVEL, DYNAMIC PLATE
• 00846468092368: THREE LEVEL, DYNAMIC PLATE
• 00846468092351: THREE LEVEL, DYNAMIC PLATE
• 00846468092344: THREE LEVEL, DYNAMIC PLATE
• 00846468092337: THREE LEVEL, DYNAMIC PLATE
• 00846468092320: THREE LEVEL, DYNAMIC PLATE