QUANTUM™* MIS CANNULATED SYSTEM 51-55-PR-35

GUDID 00846468042851

MIS ROD

Pioneer Surgical Technology, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00846468042851
• NIH Device Record Key: d9552e02-8c56-492a-a831-b611cb07b894
• Commercial Distribution Discontinuation: 2018-04-18
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: QUANTUM™* MIS CANNULATED SYSTEM
• Version Model Number: 51-55-PR-35
• Catalog Number: 51-55-PR-35
• 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	00846468042851 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101790

FDA Product Code

• NKB: Orthosis, spinal pedicle fixation, for degenerative disc disease

Sterilization

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

[00846468042851]

Moist Heat or Steam Sterilization

[00846468042851]

Moist Heat or Steam Sterilization

[00846468042851]

Moist Heat or Steam Sterilization

[00846468042851]

Moist Heat or Steam Sterilization

[00846468042851]

Moist Heat or Steam Sterilization

[00846468042851]

Moist Heat or Steam Sterilization

[00846468042851]

Moist Heat or Steam Sterilization

[00846468042851]

Moist Heat or Steam Sterilization

[00846468042851]

Moist Heat or Steam Sterilization

[00846468042851]

Moist Heat or Steam Sterilization

[00846468042851]

Moist Heat or Steam Sterilization

[00846468042851]

Moist Heat or Steam Sterilization

[00846468042851]

Moist Heat or Steam Sterilization

[00846468042851]

Moist Heat or Steam Sterilization

[00846468042851]

Moist Heat or Steam Sterilization

[00846468042851]

Moist Heat or Steam Sterilization

[00846468042851]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-19
• Device Publish Date: 2015-11-23

On-Brand Devices [QUANTUM™* MIS CANNULATED SYSTEM]

• 00846468043339: CANNULATED SCREW, POLYAXIAL
• 00846468043322: CANNULATED SCREW, POLYAXIAL
• 00846468043315: CANNULATED SCREW, POLYAXIAL
• 00846468043308: CANNULATED SCREW, POLYAXIAL
• 00846468043292: CANNULATED SCREW, FIXED
• 00846468043285: CANNULATED SCREW, FIXED
• 00846468043278: CANNULATED SCREW, FIXED
• 00846468043261: CANNULATED SCREW, FIXED
• 00846468043254: CANNULATED SCREW, FIXED
• 00846468043247: CANNULATED SCREW, FIXED
• 00846468043230: CANNULATED SCREW, FIXED
• 00846468043223: CANNULATED SCREW, POLYAXIAL
• 00846468043216: CANNULATED SCREW, POLYAXIAL
• 00846468043209: CANNULATED SCREW, POLYAXIAL
• 00846468043193: CANNULATED SCREW, POLYAXIAL
• 00846468043186: CANNULATED SCREW, POLYAXIAL
• 00846468043179: CANNULATED SCREW, POLYAXIAL
• 00846468043162: CANNULATED SCREW, FIXED
• 00846468043155: CANNULATED SCREW, FIXED
• 00846468043148: CANNULATED SCREW, FIXED
• 00846468043131: CANNULATED SCREW, FIXED
• 00846468043124: CANNULATED SCREW, FIXED
• 00846468043117: CANNULATED SCREW, POLYAXIAL
• 00846468043100: CANNULATED SCREW, POLYAXIAL
• 00846468043094: CANNULATED SCREW, POLYAXIAL
• 00846468043087: CANNULATED SCREW, POLYAXIAL
• 00846468043070: CANNULATED SCREW, POLYAXIAL
• 00846468043063: CANNULATED SCREW, FIXED
• 00846468043056: CANNULATED SCREW, FIXED
• 00846468043049: CANNULATED SCREW, FIXED
• 00846468043032: CANNULATED SCREW, FIXED
• 00846468043025: CANNULATED SCREW, FIXED
• 00846468043001: ROD, STRAIGHT
• 00846468042998: ROD, STRAIGHT
• 00846468042981: ROD, STRAIGHT
• 00846468042974: ROD, STRAIGHT
• 00846468042967: ROD, STRAIGHT
• 00846468042950: ROD, STRAIGHT
• 00846468042943: ROD, STRAIGHT
• 00846468042936: MIS ROD
• 00846468042929: MIS ROD
• 00846468042905: MIS ROD
• 00846468042899: MIS ROD
• 00846468042882: MIS ROD
• 00846468042875: MIS ROD
• 00846468042868: MIS ROD
• 00846468042851: MIS ROD
• 00846468042844: MIS ROD
• 00846468042837: MIS ROD
• 00846468042820: MIS ROD