Lat-Fuse™ Lateral Plate System

GUDID 00846468014452

NUT LOCKER

Pioneer Surgical Technology, Inc.

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00846468014452
• NIH Device Record Key: 61b0103f-7d06-4435-9f61-64bfb7db0c15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lat-Fuse™ Lateral Plate System
• Version Model Number: 38-LOCKER
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846468014452 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120724

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[00846468014452]

Moist Heat or Steam Sterilization

[00846468014452]

Moist Heat or Steam Sterilization

[00846468014452]

Moist Heat or Steam Sterilization

[00846468014452]

Moist Heat or Steam Sterilization

[00846468014452]

Moist Heat or Steam Sterilization

[00846468014452]

Moist Heat or Steam Sterilization

[00846468014452]

Moist Heat or Steam Sterilization

[00846468014452]

Moist Heat or Steam Sterilization

[00846468014452]

Moist Heat or Steam Sterilization

[00846468014452]

Moist Heat or Steam Sterilization

[00846468014452]

Moist Heat or Steam Sterilization

[00846468014452]

Moist Heat or Steam Sterilization

[00846468014452]

Moist Heat or Steam Sterilization

[00846468014452]

Moist Heat or Steam Sterilization

[00846468014452]

Moist Heat or Steam Sterilization

[00846468014452]

Moist Heat or Steam Sterilization

[00846468014452]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-05

On-Brand Devices [Lat-Fuse™ Lateral Plate System]

• 00846468078133: PLATE CADDY
• 00846468077778: INSTRUMENT CASE
• 00846468014568: TORQUE LIMITING HANDLE
• 00846468014551: ARTICULATING PLATE HOLDER
• 00846468014544: SCREW SEAT INDICATOR
• 00846468014537: RATCHETING T-HANDLE
• 00846468014520: RATCHETING PALM STYLE HANDLE
• 00846468014513: SCREW TIGHTENER
• 00846468014506: TEMPORARY HOLDING PIN, LONG
• 00846468014490: TEMPORARY HOLDING PIN
• 00846468014483: SCREW INSERTER, SELF-RETAINED
• 00846468014476: SCREW INSERTER, THREADED
• 00846468014469: IN-LINE FIXED PLATE HOLDER
• 00846468014452: NUT LOCKER
• 00846468014445: MODULAR DRILL
• 00846468014438: CENTERING SLEEVE
• 00846468014421: MODULAR AWL