Cross-Fuse® II PEEK IBF System 38-FORK-HL

GUDID 00191083033211

IMPLANT FORK

Pioneer Surgical Technology, Inc.

Orthopaedic inorganic implant inserter/extractor, reusable

• Primary Device ID: 00191083033211
• NIH Device Record Key: 3c129eaf-b4a5-4b97-8b48-7bc6addd980d
• Commercial Distribution Discontinuation: 2024-12-12
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Cross-Fuse® II PEEK IBF System
• Version Model Number: 38-FORK-HL
• Catalog Number: 38-FORK-HL
• Company DUNS: 793384496
• Company Name: Pioneer Surgical Technology, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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(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

• 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	00191083033211 [Primary]
GS1	00846468061869 [Previous]

FDA Product Code

• HXE: FORK

Sterilization

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

[00191083033211]

Moist Heat or Steam Sterilization

[00191083033211]

Moist Heat or Steam Sterilization

[00191083033211]

Moist Heat or Steam Sterilization

[00191083033211]

Moist Heat or Steam Sterilization

[00191083033211]

Moist Heat or Steam Sterilization

[00191083033211]

Moist Heat or Steam Sterilization

[00191083033211]

Moist Heat or Steam Sterilization

[00191083033211]

Moist Heat or Steam Sterilization

[00191083033211]

Moist Heat or Steam Sterilization

[00191083033211]

Moist Heat or Steam Sterilization

[00191083033211]

Moist Heat or Steam Sterilization

[00191083033211]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-20
• Device Publish Date: 2024-12-12

On-Brand Devices [Cross-Fuse® II PEEK IBF System]

• 00191083033761: Sterilization Case
• 00191083033754: Sterilization Case
• 00191083033679: TRIAL SPACER
• 00191083033662: TRIAL SPACER
• 00191083033631: TRIAL SPACER
• 00191083033624: TRIAL SPACER
• 00191083033617: TRIAL SPACER
• 00191083033600: TRIAL SPACER
• 00191083033570: TRIAL SPACER
• 00191083033525: TRIAL SPACER
• 00191083033488: TRIAL SPACER
• 00191083033440: TRIAL SPACER
• 00191083033396: TRIAL SPACER
• 00191083033358: TAMP
• 00191083033341: SLIDER
• 00191083033334: SLIDER
• 00191083033327: SLIDER
• 00191083033310: SLIDER
• 00191083033303: SLIDER
• 00191083033273: Inserter
• 00191083033242: INSERTER
• 00191083033228: INSERTER
• 00191083033167: L4/L5 TRIAL SPACER, RIGHT
• 00191083033150: L4/L5 TRIAL SPACER, LEFT
• 00191083033143: L4/L5 TRIAL SPACER, RIGHT
• 00191083033136: L4/L5 TRIAL SPACER, LEFT
• 00191083033129: L4/L5 TRIAL SPACER, RIGHT
• 00191083033112: L4/L5 TRIAL SPACER, LEFT
• 00191083033105: L4/L5 TRIAL SPACER, RIGHT
• 00191083033099: L4/L5 TRIAL SPACER, LEFT
• 00191083033082: L4/L5 TRIAL SPACER, RIGHT
• 00191083033075: L4/L5 TRIAL SPACER, LEFT
• 00191083032788: L4/L5 TRIAL SPACER
• 00191083032771: L4/L5 TRIAL SPACER
• 00191083032764: L4/L5 TRIAL SPACER
• 00191083032733: L4/L5 TRIAL SPACER
• 00191083032696: L4/L5 TRIAL SPACER
• 00191083032689: L4/L5 TRIAL SPACER
• 00191083032672: L4/L5 TRIAL SPACER
• 00191083032641: L4/L5 TRIAL SPACER
• 00191083032597: L4/L5 TRIAL SPACER
• 00191083032542: ANGLED INSERTER
• 00191083043272: INTERBODY FUSION DEVICE
• 00191083043265: INTERBODY FUSION DEVICE
• 00191083042695: INTERBODY FUSION DEVICE
• 00191083042688: INTERBODY FUSION DEVICE
• 00191083042671: INTERBODY FUSION DEVICE
• 00191083042664: INTERBODY FUSION DEVICE
• 00191083042657: INTERBODY FUSION DEVICE
• 00191083042640: INTERBODY FUSION DEVICE