Laminoplasty 52-2308

GUDID 10889981076009

Graft Plate, Single, 8mm

SEASPINE ORTHOPEDICS CORPORATION

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 10889981076009
• NIH Device Record Key: 4b4e1619-84ab-4410-9dcf-fd7a9999f2b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Laminoplasty
• Version Model Number: 52-2308
• Catalog Number: 52-2308
• 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: 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(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
• 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
• 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 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 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	10889981076009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150469

FDA Product Code

• NQW: ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL

Sterilization

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

[10889981076009]

Moist Heat or Steam Sterilization

[10889981076009]

Moist Heat or Steam Sterilization

[10889981076009]

Moist Heat or Steam Sterilization

[10889981076009]

Moist Heat or Steam Sterilization

[10889981076009]

Moist Heat or Steam Sterilization

[10889981076009]

Moist Heat or Steam Sterilization

[10889981076009]

Moist Heat or Steam Sterilization

[10889981076009]

Moist Heat or Steam Sterilization

[10889981076009]

Moist Heat or Steam Sterilization

[10889981076009]

Moist Heat or Steam Sterilization

[10889981076009]

Moist Heat or Steam Sterilization

[10889981076009]

Moist Heat or Steam Sterilization

[10889981076009]

Moist Heat or Steam Sterilization

[10889981076009]

Moist Heat or Steam Sterilization

[10889981076009]

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: 2016-07-15

On-Brand Devices [Laminoplasty]

• 10889981135010: Graft Block Holder
• 10889981129811: Laminoplasty Graft Plate, Side by Side Caddy BOM
• 10889981129699: Laminoplasty Graft Plate, Single Caddy BOM
• 10889981127824: Laminoplasty Graft Plate, in-Line Caddy BOM
• 10889981123895: Laminoplasty 14mm Plate Caddy
• 10889981120597: Stop Drill, 11mm L
• 10889981119034: Laminoplasty Instrument Set
• 10889981096113: 6mm Mouth, Single Plate Caddy
• 10889981096106: 4mm Mouth, Single Plate Caddy
• 10889981096090: Optional Plate and Screw Caddy
• 10889981096083: Self Drilling Lamina Screw Caddy
• 10889981096076: Hinge Plate Implant Caddy
• 10889981096069: 6mm Mouth, In-Line Implant Caddy
• 10889981096052: 4mm Mouth, In-Line Implant Caddy
• 10889981096045: 6mm Mouth, Side by Side Implant Caddy
• 10889981096038: 4mm Mouth, Side by Side Implant Caddy
• 10889981096021: Implant Tray
• 10889981096014: Instrument Tray
• 10889981095963: Screwdriver
• 10889981095956: Universal Handle
• 10889981095932: Plate Holder with AIO Guide
• 10889981095925: Plate Holder, Straight
• 10889981095918: Plate Holder
• 10889981095901: Sounder/Probe
• 10889981095895: Stop Drill, 9mm L
• 10889981095888: Stop Drill, 7mm L
• 10889981095871: Stop Drill, 5mm L
• 10889981095857: Short Drill, 5mm L
• 10889981095840: Drill Guide
• 10889981076047: Graft Plate, Single, 12mm
• 10889981076023: Graft Plate, Single, 10mm
• 10889981076009: Graft Plate, Single, 8mm
• 10889981075989: Graft Plate, Single, 6mm
• 10889981075934: Graft Plate, In-Line, 12mm
• 10889981075910: Graft Plate, In-Line, 10mm
• 10889981075897: Graft Plate, In-Line, 8mm
• 10889981075873: Graft Plate, In-Line, 6mm
• 10889981075828: Graft Plate, Side by Side, 12mm
• 10889981075804: Graft Plate, Side by Side, 10mm
• 10889981075781: Graft Plate, Side by Side, 8mm
• 10889981075767: Graft Plate, Side by Side, 6mm
• 10889981062637: Laminoplasty Optional Implant Set
• 10889981062620: Laminoplasty Implant Set
• 10889981062170: Lamina Sizing Trial, 6mm
• 10889981062163: Lamina Sizing Trial, 4mm
• 10889981062156: Plate Sizing Trial, 16mm L
• 10889981062149: Plate Sizing Trial, 14mm L
• 10889981062132: Plate Sizing Trial, 12mm L
• 10889981062125: Plate Sizing Trial, 10mm L
• 10889981062118: Plate Sizing Trial, 8mm L