Atoll 16-21-1906

GUDID 10889981033859

Offset Hook (right) - large. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connec

SEASPINE ORTHOPEDICS CORPORATION

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10889981033859
• NIH Device Record Key: 11f13ffc-5cf8-4785-986e-e60e3ef58985
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atoll
• Version Model Number: 16-21-1906
• Catalog Number: 16-21-1906
• Company DUNS: 079840876
• Company Name: SEASPINE ORTHOPEDICS CORPORATION
• 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: false
• 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(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981033859 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080790

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[10889981033859]

Moist Heat or Steam Sterilization

[10889981033859]

Moist Heat or Steam Sterilization

[10889981033859]

Moist Heat or Steam Sterilization

[10889981033859]

Moist Heat or Steam Sterilization

[10889981033859]

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: 2015-09-24

On-Brand Devices [Atoll]

• 10889981143077: Transition Rod 3.5mm-5.5mm290mm
• 10889981137397: Atoll Instrument Sterilization Case Misc Screw Caddy, Small Assembly
• 10889981137380: Atoll Sterilization Case Misc Screw Caddy, Large Assembly
• 10889981135218: Sterilization Case Base
• 10889981135201: Sterilization Case Lid
• 10889981135195: Sterilization Case Bottom Tray
• 10889981135188: Sterilization Case Middle Tray
• 10889981135171: Sterilization Case 4.0mm Screw Caddy Lid
• 10889981135164: Sterilization Case Locking Screw Caddy
• 10889981135157: Sterilization Case Hooks & CC Caddy
• 10889981135140: Sterilization Case 4.0mm Screw Caddy
• 10889981135133: Sterilization Case 3.5mm Screw Caddy
• 10889981135126: Sterilization Case Locking Screw Lid
• 10889981135119: Sterilization Case Hooks & CC Lid
• 10889981135102: Sterilization Case 3.5mm Caddy Lid
• 10889981135096: Sterilization Case Top Tray
• 10889981129750: Atoll Smooth Shaft Screw Caddy
• 10889981129743: Atoll Polyaxial Long Screw Caddy
• 10889981129545: Atoll Polyaxial Long Screw Caddy
• 10889981129538: Atoll Smooth Shaft Screw Caddy
• 10889981123130: In Situ Rod, Bender, Right
• 10889981123123: In Situ Rod, Bender, Left
• 10889981121174: Plate Caddy Assembly
• 10889981118716: ATOLL POSTERIOR CERVICAL SPINAL SYSTEM IMPLANTS / DISPOSABLES
• 10889981118709: ATOLL OCCIPITAL SPINAL SYSTEM IMPLANTS / DISPOSABLES
• 10889981109806: Screw Caddy Assembly
• 10889981109790: Occipital Delivery Case
• 10889981109783: Transition Set Case
• 10889981109776: Case
• 10889981109769: Counter Torque Tube
• 10889981109752: Occipital Rod Bending Tube
• 10889981109745: Occipital Plate Bending Pliers
• 10889981109738: Plate Bender - Occipital
• 10889981109721: Screw Driver Flexible - Occipital
• 10889981109714: Screw Driver - Occipital
• 10889981109707: Flexible Instrument Holder
• 10889981109691: Plate Holder - Occipital
• 10889981109639: Triple Barrel Drill Guide - Occipital
• 10889981109622: Adjustable Drill Guide
• 10889981109615: Occipital Plate Holding Pin
• 10889981109608: 4.0mm Flexible Occipital Tap
• 10889981109592: 4.0mm Occipital Tap
• 10889981109585: 4.0mm Flexible Occipital drill
• 10889981109578: 4.0mm Occipital Drill
• 10889981109561: 4.0mm DRILL-DISPOSABLE
• 10889981109554: Sharp Drill 3.5mm (single use only)
• 10889981109547: Drill - Smooth Shaft - 4.0mm
• 10889981109530: Drill - Smooth Shaft - 3.5mm
• 10889981109523: Self retaining Set Screw Inserter
• 10889981109516: Clamshell Inserter