STREAMLINE®* OCT OCCIPITO-CERVICO-THORACIC SYSTEM 26-PA-40-22

GUDID 00846468029913

PEDICLE SCREW, POLYAXIAL

Pioneer Surgical Technology, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00846468029913
• NIH Device Record Key: 3ca81867-9a11-4717-9fcc-6cc6a4999d61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STREAMLINE®* OCT OCCIPITO-CERVICO-THORACIC SYSTEM
• Version Model Number: 26-PA-40-22
• Catalog Number: 26-PA-40-22
• 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

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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00846468029913 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150254

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[00846468029913]

Moist Heat or Steam Sterilization

[00846468029913]

Moist Heat or Steam Sterilization

[00846468029913]

Moist Heat or Steam Sterilization

[00846468029913]

Moist Heat or Steam Sterilization

[00846468029913]

Moist Heat or Steam Sterilization

[00846468029913]

Moist Heat or Steam Sterilization

[00846468029913]

Moist Heat or Steam Sterilization

[00846468029913]

Moist Heat or Steam Sterilization

[00846468029913]

Moist Heat or Steam Sterilization

[00846468029913]

Moist Heat or Steam Sterilization

[00846468029913]

Moist Heat or Steam Sterilization

[00846468029913]

Moist Heat or Steam Sterilization

[00846468029913]

Moist Heat or Steam Sterilization

[00846468029913]

Moist Heat or Steam Sterilization

[00846468029913]

Moist Heat or Steam Sterilization

[00846468029913]

Moist Heat or Steam Sterilization

[00846468029913]

Moist Heat or Steam Sterilization

[00846468029913]

Moist Heat or Steam Sterilization

[00846468029913]

Moist Heat or Steam Sterilization

[00846468029913]

Moist Heat or Steam Sterilization

[00846468029913]

Moist Heat or Steam Sterilization

[00846468029913]

Moist Heat or Steam Sterilization

[00846468029913]

Moist Heat or Steam Sterilization

[00846468029913]

Moist Heat or Steam Sterilization

[00846468029913]

Moist Heat or Steam Sterilization

[00846468029913]

Moist Heat or Steam Sterilization

[00846468029913]

Moist Heat or Steam Sterilization

[00846468029913]

Moist Heat or Steam Sterilization

[00846468029913]

Moist Heat or Steam Sterilization

[00846468029913]

Moist Heat or Steam Sterilization

[00846468029913]

Moist Heat or Steam Sterilization

[00846468029913]

Moist Heat or Steam Sterilization

[00846468029913]

Moist Heat or Steam Sterilization

[00846468029913]

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: 2015-11-26

On-Brand Devices [STREAMLINE®* OCT OCCIPITO-CERVICO-THORACIC SYSTEM]

• 00846468058210: SCREW, HIGH ANGLE
• 00846468058180: SCREW, HIGH ANGLE
• 00846468058159: SCREW, HIGH ANGLE
• 00846468058128: SCREW, HIGH ANGLE
• 00846468058111: SCREW, HIGH ANGLE
• 00846468058104: SCREW, HIGH ANGLE
• 00846468058098: SCREW, HIGH ANGLE
• 00846468058081: SCREW, HIGH ANGLE
• 00846468058074: SCREW, HIGH ANGLE
• 00846468058067: SCREW, HIGH ANGLE
• 00846468058050: SCREW, HIGH ANGLE
• 00846468058043: SCREW, HIGH ANGLE
• 00846468058036: SCREW, HIGH ANGLE
• 00846468058029: SCREW, HIGH ANGLE
• 00846468057794: SCREW, HIGH ANGLE
• 00846468057763: SCREW, HIGH ANGLE
• 00846468057732: SCREW, HIGH ANGLE
• 00846468057701: SCREW, HIGH ANGLE
• 00846468057695: SCREW, HIGH ANGLE
• 00846468057688: SCREW, HIGH ANGLE
• 00846468057671: SCREW, HIGH ANGLE
• 00846468057664: SCREW, HIGH ANGLE
• 00846468057657: SCREW, HIGH ANGLE
• 00846468057640: SCREW, HIGH ANGLE
• 00846468057633: SCREW, HIGH ANGLE
• 00846468057626: SCREW, HIGH ANGLE
• 00846468057619: SCREW, HIGH ANGLE
• 00846468057602: SCREW, HIGH ANGLE
• 00846468057343: LOCKING NUT, HEAD-TO-HEAD CROSSLINK
• 00846468057336: SET SCREW, HEAD-TO-HEAD CROSSLINK
• 00846468057329: OFFSET CONNECTOR, ANGLED
• 00846468057312: OFFSET CONNECTOR, STRAIGHT
• 00846468057305: HOOK, STRAIGHT, 7mm THROAT
• 00846468057299: HOOK, STRAIGHT, 5mm THROAT
• 00846468057268: HEAD-TO-HEAD CROSSLINK - L
• 00846468057251: HEAD-TO-HEAD CROSSLINK - M
• 00846468057244: HEAD-TO-HEAD CROSSLINK - S
• 00846468057237: HEAD-TO-HEAD CROSSLINK - XS
• 00846468054632: ROD-TO-ROD CROSSLINK, LARGE
• 00846468054625: ROD-TO-ROD CROSSLINK, MEDIUM
• 00846468054618: ROD-TO-ROD CROSSLINK, SMALL
• 00846468030254: SET SCREW
• 00846468030193: Rocker reducer
• 00846468030155: PEDICLE SCREW, POLYAXIAL
• 00846468030131: PEDICLE SCREW, POLYAXIAL
• 00846468030117: PEDICLE SCREW, POLYAXIAL
• 00846468030094: PEDICLE SCREW, POLYAXIAL
• 00846468030070: PEDICLE SCREW, POLYAXIAL
• 00846468030056: PEDICLE SCREW, POLYAXIAL
• 00846468030032: PEDICLE SCREW, POLYAXIAL