QUANTUM™* SPINAL FIXATION SYSTEM 10-55-PR-105

GUDID 00846468019082

ROD, PRE-BENT

Pioneer Surgical Technology, Inc.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00846468019082
• NIH Device Record Key: eb84e0fa-3d7a-4ab8-9fb5-bf35534a3abf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QUANTUM™* SPINAL FIXATION SYSTEM
• Version Model Number: 10-55-PR-105
• Catalog Number: 10-55-PR-105
• 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	00846468019082 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101790

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[00846468019082]

Moist Heat or Steam Sterilization

[00846468019082]

Moist Heat or Steam Sterilization

[00846468019082]

Moist Heat or Steam Sterilization

[00846468019082]

Moist Heat or Steam Sterilization

[00846468019082]

Moist Heat or Steam Sterilization

[00846468019082]

Moist Heat or Steam Sterilization

[00846468019082]

Moist Heat or Steam Sterilization

[00846468019082]

Moist Heat or Steam Sterilization

[00846468019082]

Moist Heat or Steam Sterilization

[00846468019082]

Moist Heat or Steam Sterilization

[00846468019082]

Moist Heat or Steam Sterilization

[00846468019082]

Moist Heat or Steam Sterilization

[00846468019082]

Moist Heat or Steam Sterilization

[00846468019082]

Moist Heat or Steam Sterilization

[00846468019082]

Moist Heat or Steam Sterilization

[00846468019082]

Moist Heat or Steam Sterilization

[00846468019082]

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: 2015-11-23

On-Brand Devices [QUANTUM™* SPINAL FIXATION SYSTEM]

• 00846468050559: ROD, HEX END
• 00846468022211: THORACIC LAMINAR HOOK, SMALL
• 00846468022204: THORACIC LAMINAR HOOK, LARGE
• 00846468022198: THORACIC LAMINAR HOOK, ANGLED, RIGHT
• 00846468022174: THORACIC LAMINAR HOOK, ANGLED, LEFT
• 00846468021603: ROD CONNECTOR, PARALLEL, MULTI
• 00846468021597: ROD CONNECTOR, PARALLEL
• 00846468021580: ROD CONNECTOR, END TO END, MULTI
• 00846468021573: ROD CONNECTOR, END TO END
• 00846468021528: PRE CONTOURED, J-ROD, RIGHT
• 00846468021511: PRE CONTOURED, J-ROD, LEFT
• 00846468021504: PRE CONTOURED, J-ROD, RIGHT
• 00846468021498: PRE CONTOURED, J-ROD, LEFT
• 00846468021481: PRE CONTOURED, J-ROD, RIGHT
• 00846468021474: PRE CONTOURED, J-ROD, LEFT
• 00846468021467: PRE CONTOURED, J-ROD, RIGHT
• 00846468021450: PRE CONTOURED, J-ROD, LEFT
• 00846468021443: PRE CONTOURED, J-ROD, RIGHT
• 00846468021436: PRE CONTOURED, J-ROD, LEFT
• 00846468021429: PRE CONTOURED, J-ROD, RIGHT
• 00846468021412: PRE CONTOURED, J-ROD, LEFT
• 00846468021405: PRE CONTOURED, J-ROD, RIGHT
• 00846468021399: PRE CONTOURED, J-ROD, LEFT
• 00846468021320: PEDICLE HOOK, SMALL
• 00846468021313: PEDICLE HOOK, MEDIUM
• 00846468021306: PEDICLE HOOK, LARGE
• 00846468020989: LATERAL OFFSET CONNECTOR
• 00846468020972: LATERAL OFFSET CONNECTOR
• 00846468020965: LATERAL OFFSET CONNECTOR
• 00846468020958: LAMINAR HOOK, LUMBAR, SMALL
• 00846468020934: LAMINAR HOOK, LUMBAR, LARGE
• 00846468020927: LAMINAR HOOK EXTENDED, LUMBAR, SMALL
• 00846468020903: LAMINAR HOOK EXTENDED, LUMBAR, LARGE
• 00846468020897: LAMINAR HOOK, OFFSET RIGHT
• 00846468020880: LAMINAR HOOK, OFFSET LEFT
• 00846468020866: LOCKING CAP
• 00846468020309: PEDICLE SCREW, FIXED
• 00846468020293: PEDICLE SCREW, FIXED
• 00846468020286: PEDICLE SCREW, FIXED
• 00846468020279: PEDICLE SCREW, FIXED
• 00846468020262: PEDICLE SCREW, FIXED
• 00846468020255: PEDICLE SCREW, FIXED
• 00846468020248: PEDICLE SCREW, FIXED
• 00846468020231: PEDICLE SCREW, FIXED
• 00846468020224: PEDICLE SCREW, FIXED
• 00846468020217: PEDICLE SCREW, FIXED
• 00846468020200: PEDICLE SCREW, FIXED
• 00846468020194: PEDICLE SCREW, FIXED
• 00846468020187: PEDICLE SCREW, FIXED
• 00846468020170: PEDICLE SCREW, FIXED