Atoll™ 16-12-4030

GUDID 10889981052584

4.0mm x 30mm Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and conne

SEASPINE ORTHOPEDICS CORPORATION

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

• Primary Device ID: 10889981052584
• NIH Device Record Key: 4e4b2dd8-ff41-4319-ac39-848ed11bc8a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atoll™
• Version Model Number: 16-12-4030
• Catalog Number: 16-12-4030
• 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

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981052584 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070638

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[10889981052584]

Moist Heat or Steam Sterilization

[10889981052584]

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™]

• 10889981053079: 4.5mm x 50mm Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine
• 10889981053062: 4.5mm x 45mm Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine
• 10889981053055: 4.5mm x 40mm Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine
• 10889981053048: 4.5mm x 35mm Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine
• 10889981053031: 4.5mm x 30mm Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine
• 10889981053024: 4.5mm x 28mm Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine
• 10889981053017: 4.5mm x 26mm Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine
• 10889981053000: 4.5mm x 24mm Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine
• 10889981052997: 4.5mm x 22mm Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine
• 10889981052980: 4.5mm x 20mm Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine
• 10889981052973: 4.5mm x 18mm Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine
• 10889981052966: 4.5mm x 16mm Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine
• 10889981052959: 4.5mm x 14mm Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine
• 10889981052942: 4.5mm x 12mm Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine
• 10889981052935: 4.5mm x 10mm Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine
• 10889981052928: Offset Hook (right) - medium. The Atoll OCT Spinal System is intended for use as an aid in spine
• 10889981052911: Offset Hook (right) - small. The Atoll OCT Spinal System is intended for use as an aid in spine
• 10889981052904: Offset Hook (left) - large. The Atoll OCT Spinal System is intended for use as an aid in spine f
• 10889981052898: Offset Hook (left) - small. The Atoll OCT Spinal System is intended for use as an aid in spine f
• 10889981052881: Inline Hook - small. The Atoll OCT Spinal System is intended for use as an aid in spine fusion.
• 10889981052874: 3.5mm x 400mm Rod. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It
• 10889981052867: Locking Screw Assembly. The Atoll OCT Spinal System is intended for use as an aid in spine fusio
• 10889981052850: 4.0mm x 38mm Smooth Shaft Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an
• 10889981052843: 4.0mm x 36mm Smooth Shaft Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an
• 10889981052836: 4.0mm x 34mm Smooth Shaft Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an
• 10889981052829: 4.0mm x 32mm Smooth Shaft Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an
• 10889981052812: 4.0mm x 30mm Smooth Shaft Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an
• 10889981052805: 4.0mm x 28mm Smooth Shaft Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an
• 10889981052799: 4.0mm x 26mm Smooth Shaft Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an
• 10889981052782: 4.0mm x 24mm Smooth Shaft Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an
• 10889981052775: 4.0mm x 22mm Smooth Shaft Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an
• 10889981052768: 4.0mm x 20mm Smooth Shaft Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an
• 10889981052751: 4.0mm x 18mm Smooth Shaft Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an
• 10889981052744: 3.5mm x 38mm Smooth Shaft Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an
• 10889981052737: 3.5mm x 36mm Smooth Shaft Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an
• 10889981052720: 3.5mm x 34mm Smooth Shaft Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an
• 10889981052713: 3.5mm x 32mm Smooth Shaft Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an
• 10889981052706: 3.5mm x 30mm Smooth Shaft Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an
• 10889981052690: 3.5mm x 28mm Smooth Shaft Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an
• 10889981052683: 3.5mm x 26mm Smooth Shaft Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an
• 10889981052676: 3.5mm x 24mm Smooth Shaft Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an
• 10889981052669: 3.5mm x 22mm Smooth Shaft Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an
• 10889981052652: 3.5mm x 20mm Smooth Shaft Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an
• 10889981052645: 3.5mm x 18mm Smooth Shaft Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an
• 10889981052638: 4.5mm x 8mm Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine
• 10889981052621: 4.0mm x 50mm Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine
• 10889981052614: 4.0mm x 45mm Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine
• 10889981052607: 4.0mm x 40mm Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine
• 10889981052591: 4.0mm x 35mm Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine
• 10889981052584: 4.0mm x 30mm Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine