Atoll 16-32-4513

GUDID 10889981034436

4.5mm Self Tapping Occipital Screw, 13mm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rod

SEASPINE ORTHOPEDICS CORPORATION

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10889981034436
• NIH Device Record Key: c60fa790-0e25-4bdf-83aa-06f05096875e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atoll
• Version Model Number: 16-32-4513
• Catalog Number: 16-32-4513
• 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
• 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	10889981034436 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083863

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[10889981034436]

Moist Heat or Steam Sterilization

[10889981034436]

Moist Heat or Steam Sterilization

[10889981034436]

Moist Heat or Steam Sterilization

[10889981034436]

Moist Heat or Steam Sterilization

[10889981034436]

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