Atoll™ 16-10-3528

GUDID 10889981052195

3.5mm x 28mm Standard Screw. 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: 10889981052195
• NIH Device Record Key: 87aa35b7-049f-4b8d-88fc-8a063c629e4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atoll™
• Version Model Number: 16-10-3528
• Catalog Number: 16-10-3528
• 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	10889981052195 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070638

FDA Product Code

• MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

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

[10889981052195]

Moist Heat or Steam Sterilization

[10889981052195]

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