BodyForm™ 19-11-0035

GUDID 10889981057862

Thoracic 35mm Bone Screw

SEASPINE ORTHOPEDICS CORPORATION

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 10889981057862
• NIH Device Record Key: 089335ae-bf5d-4277-8ca9-cd49af48852b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BodyForm™
• Version Model Number: 19-11-0035
• Catalog Number: 19-11-0035
• 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
• 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	10889981057862 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072407

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[10889981057862]

Moist Heat or Steam Sterilization

[10889981057862]

Moist Heat or Steam Sterilization

[10889981057862]

Moist Heat or Steam Sterilization

[10889981057862]

Moist Heat or Steam Sterilization

[10889981057862]

Moist Heat or Steam Sterilization

[10889981057862]

Moist Heat or Steam Sterilization

[10889981057862]

Moist Heat or Steam Sterilization

[10889981057862]

Moist Heat or Steam Sterilization

[10889981057862]

Moist Heat or Steam Sterilization

[10889981057862]

Moist Heat or Steam Sterilization

[10889981057862]

Moist Heat or Steam Sterilization

[10889981057862]

Moist Heat or Steam Sterilization

[10889981057862]

Moist Heat or Steam Sterilization

[10889981057862]

Moist Heat or Steam Sterilization

[10889981057862]

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 [BodyForm™]

• 10889981062194: BodyForm Thoraco-Lumbar Fixation System
• 10889981057923: Thoracic Set Screw
• 10889981057916: Thoracic 60mm Bone Screw
• 10889981057909: Thoracic 55mm Bone Screw
• 10889981057893: Thoracic 50mm Bone Screw
• 10889981057886: Thoracic 45mm Bone Screw
• 10889981057879: Thoracic 40mm Bone Screw
• 10889981057862: Thoracic 35mm Bone Screw
• 10889981057855: Thoracic 30mm Bone Screw
• 10889981057848: Thoracic 25mm Bone Screw
• 10889981057831: Thoracic 20mm Bone Screw
• 10889981057824: Thoracic 99mm Plate
• 10889981057817: Thoracic 95mm Plate
• 10889981057800: Thoracic 91mm Plate
• 10889981057794: Thoracic 87mm Plate
• 10889981057787: Thoracic 83mm Plate
• 10889981057770: Thoracic 79mm Plate
• 10889981057763: Thoracic 76mm Plate
• 10889981057756: Thoracic 73mm Plate
• 10889981057749: Thoracic 70mm Plate
• 10889981057732: Thoracic 67mm Plate
• 10889981057725: Thoracic 64mm Plate
• 10889981057718: Thoracic 62mm Plate
• 10889981057701: Thoracic 60mm Plate
• 10889981057695: Thoracic 44mm Plate
• 10889981057688: Thoracic 43mm Plate
• 10889981057671: Thoracic 42mm Plate
• 10889981057664: Thoracic 41mm Plate
• 10889981057657: Thoracic 40mm Plate