Quantum Spinal Fixation System 10-PJC5001050-L

GUDID 00846468090456

PRE CONTOURED, J-ROD, LEFT

Pioneer Surgical Technology, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00846468090456
• NIH Device Record Key: aed4f7ff-29d2-4ed5-a14b-14ca6beb4403
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quantum Spinal Fixation System
• Version Model Number: 10-PJC5001050-L
• Catalog Number: 10-PJC5001050-L
• 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(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00846468090456 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101790

FDA Product Code

• MNI: Orthosis, spinal pedicle fixation

Sterilization

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

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

Moist Heat or Steam Sterilization

[00846468090456]

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 [Quantum Spinal Fixation System]

• 00846468060350: QUANTUM SCREW REMOVER
• 00846468022358: YOKE FORK
• 00846468022341: X-LINK HOLDER
• 00846468022334: X-LINK BENDER, PERPENDICULAR
• 00846468022327: X-LINK BENDER, PARALLEL
• 00846468022310: WRENCH, X-LINK
• 00846468022303: X-LINK GAGE
• 00846468022297: DRIVER, X-LINK
• 00846468022280: CASE, X-LINK
• 00846468022259: GAGE, X-LINK, VARIABLE, 60mm-80mm
• 00846468022242: GAGE, X-LINK, VARIABLE, 40mm-60mm
• 00846468022235: GAGE, X-LINK, VARIABLE, 30mm-40mm
• 00846468022228: CADDY, X-LINK, VARIABLE
• 00846468022112: TAP SLEEVE
• 00846468022105: TAP, 7.25mm, EXTENDED LENGTH
• 00846468022099: TAP, 7.25mm, 1" THREAD
• 00846468022082: TAP, 7.25mm
• 00846468022075: TAP, 6.25mm, EXTENDED LENGTH
• 00846468022068: TAP, 6.25mm, 1" THREAD
• 00846468022051: TAP, 6.25mm
• 00846468022044: TAP, 5.25mm, EXTENDED LENGTH
• 00846468022037: TAP, 5.25mm, 1" THREAD
• 00846468022020: TAP, 5.25mm
• 00846468022006: TAP, 4.25mm, 1" THREAD
• 00846468021993: TAP, 4.25mm
• 00846468021986: TAP, 3.5mm
• 00846468021955: STABILIZING TUBE
• 00846468021863: SCREW INSERTER
• 00846468021856: SCREW INSERTER
• 00846468021849: SCREW GAGE
• 00846468021771: COUNTER TORQUE WRENCH
• 00846468021726: ROD FORCEPS, 25°, Ø 5.5mm
• 00846468021696: CADDY, ROD, STRAIGHT
• 00846468021689: CADDY, ROD, PRE-BENT
• 00846468021672: CADDY, ROD
• 00846468021658: ROCKER
• 00846468021627: X-LINK REMOVAL WRENCH
• 00846468021566: RAPID REDUCER
• 00846468021276: ROD PERSUADER
• 00846468021214: CADDY, SCREW, POLYAXIAL 7.75mm
• 00846468021207: CADDY, SCREW, POLYAXIAL 6.75mm
• 00846468021191: CADDY, SCREW, POLYAXIAL 5.75mm
• 00846468021184: CADDY, SCREW, POLYAXIAL 4.75mm
• 00846468021177: CADDY, SCREW, POLYAXIAL 4.00mm
• 00846468021160: CADDY, ILIAC BOLT, POLYAXIAL
• 00846468021153: CADDY, ILIAC BOLT, POLYAXIAL
• 00846468021139: OSTEOTOME
• 00846468021085: ROD REDUCER
• 00846468021078: ROD REDUCER, ANGLED
• 00846468021009: LOCKING TUBE