QUANTUM™* FLEX

GUDID 00846468022419

ROD, PRE-BENT

Pioneer Surgical Technology, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00846468022419
• NIH Device Record Key: 2225f8c4-1a04-4b2c-a26f-b9603cf8eba2
• Commercial Distribution Discontinuation: 2017-01-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: QUANTUM™* FLEX
• Version Model Number: 13-55-PR-45
• 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	00846468022419 [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

[00846468022419]

Moist Heat or Steam Sterilization

[00846468022419]

Moist Heat or Steam Sterilization

[00846468022419]

Moist Heat or Steam Sterilization

[00846468022419]

Moist Heat or Steam Sterilization

[00846468022419]

Moist Heat or Steam Sterilization

[00846468022419]

Moist Heat or Steam Sterilization

[00846468022419]

Moist Heat or Steam Sterilization

[00846468022419]

Moist Heat or Steam Sterilization

[00846468022419]

Moist Heat or Steam Sterilization

[00846468022419]

Moist Heat or Steam Sterilization

[00846468022419]

Moist Heat or Steam Sterilization

[00846468022419]

Moist Heat or Steam Sterilization

[00846468022419]

Moist Heat or Steam Sterilization

[00846468022419]

Moist Heat or Steam Sterilization

[00846468022419]

Moist Heat or Steam Sterilization

[00846468022419]

Moist Heat or Steam Sterilization

[00846468022419]

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: 2015-11-06

On-Brand Devices [QUANTUM™* FLEX]

• 00846468022471: ROD, PRE-BENT
• 00846468022464: ROD, PRE-BENT
• 00846468022457: ROD, PRE-BENT
• 00846468022440: ROD, PRE-BENT
• 00846468022433: ROD, PRE-BENT
• 00846468022426: ROD, PRE-BENT
• 00846468022419: ROD, PRE-BENT
• 00846468022402: ROD, PRE-BENT
• 00846468022396: ROD, PRE-BENT
• 00846468022389: ROD, PRE-BENT
• 00846468022372: ROD, PRE-BENT
• 00846468022365: ROD, PRE-BENT