Cequence 0205-0016

GUDID 00846468017330

Five Level Semi-Constrained Plate

Pioneer Surgical Technology, Inc.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00846468017330
• NIH Device Record Key: 98ee30b0-0c3f-4756-8593-4050ba264547
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cequence
• Version Model Number: 0205-0016
• Catalog Number: 0205-0016
• 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

Device Dimensions

• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846468017330 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081132

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

Moist Heat or Steam Sterilization

[00846468017330]

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: 2015-12-08

On-Brand Devices [Cequence]

• 00846468018085: Constrained Rescue Screw, self-tapping
• 00846468018078: Constrained Rescue Screw, self-tapping
• 00846468018061: Constrained Rescue Screw, self-tapping
• 00846468018054: Constrained Rescue Screw, self-tapping
• 00846468018047: Constrained Screw, self-tapping
• 00846468018030: Constrained Screw, self-tapping
• 00846468018023: Constrained Screw, self-tapping
• 00846468018016: Constrained Screw, self-tapping
• 00846468018009: Constrained Screw, self-drilling
• 00846468017996: Constrained Screw, self-drilling
• 00846468017989: Constrained Screw, self-drilling
• 00846468017972: Constrained Screw, self-drilling
• 00846468017965: Five Level Constrained Plate
• 00846468017958: Five Level Constrained Plate
• 00846468017941: Five Level Constrained Plate
• 00846468017934: Five Level Constrained Plate
• 00846468017927: Five Level Constrained Plate
• 00846468017910: Five Level Constrained Plate
• 00846468017903: Five Level Constrained Plate
• 00846468017897: Five Level Constrained Plate
• 00846468017880: Five Level Constrained Plate
• 00846468017873: Four Level Constrained Plate
• 00846468017866: Four Level Constrained Plate
• 00846468017859: Four Level Constrained Plate
• 00846468017842: Four Level Constrained Plate
• 00846468017835: Four Level Constrained Plate
• 00846468017828: Four Level Constrained Plate
• 00846468017811: Four Level Constrained Plate
• 00846468017804: Four Level Constrained Plate
• 00846468017798: Four Level Constrained Plate
• 00846468017781: Three Level Constrained Plate
• 00846468017774: Three Level Constrained Plate
• 00846468017767: Three Level Constrained Plate
• 00846468017750: Three Level Constrained Plate
• 00846468017743: Three Level Constrained Plate
• 00846468017736: Three Level Constrained Plate
• 00846468017729: Three Level Constrained Plate
• 00846468017712: Three Level Constrained Plate
• 00846468017705: Three Level Constrained Plate
• 00846468017699: Two Level Constrained Plate
• 00846468017682: Two Level Constrained Plate
• 00846468017675: Two Level Constrained Plate
• 00846468017668: Two Level Constrained Plate
• 00846468017651: Two Level Constrained Plate
• 00846468017644: Two Level Constrained Plate
• 00846468017637: Two Level Constrained Plate
• 00846468017620: Two Level Constrained Plate
• 00846468017613: Two Level Constrained Plate
• 00846468017606: One Level Constrained Plate
• 00846468017590: One Level Constrained Plate