BodyForm™ Thoraco-Lumbar 20-12-0001

GUDID 10889981048402

Thoraco-Lumbar Set Screw (BFSS-952-B)

SEASPINE ORTHOPEDICS CORPORATION

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 10889981048402
• NIH Device Record Key: 81454cdc-27c8-433d-a816-8f380780253a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BodyForm™ Thoraco-Lumbar
• Version Model Number: 20-12-0001
• Catalog Number: 20-12-0001
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	10889981048402 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983622

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[10889981048402]

Moist Heat or Steam Sterilization

[10889981048402]

Moist Heat or Steam Sterilization

[10889981048402]

Moist Heat or Steam Sterilization

[10889981048402]

Moist Heat or Steam Sterilization

[10889981048402]

Moist Heat or Steam Sterilization

[10889981048402]

Moist Heat or Steam Sterilization

[10889981048402]

Moist Heat or Steam Sterilization

[10889981048402]

Moist Heat or Steam Sterilization

[10889981048402]

Moist Heat or Steam Sterilization

[10889981048402]

Moist Heat or Steam Sterilization

[10889981048402]

Moist Heat or Steam Sterilization

[10889981048402]

Moist Heat or Steam Sterilization

[10889981048402]

Moist Heat or Steam Sterilization

[10889981048402]

Moist Heat or Steam Sterilization

[10889981048402]

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™ Thoraco-Lumbar]

• 10889981048402: Thoraco-Lumbar Set Screw (BFSS-952-B)
• 10889981048396: Thoraco-Lumbar 60mm Bone Screw (BFS-700-60-B)
• 10889981048389: Thoraco-Lumbar 55mm Bone Screw (BFS-700-55-B)
• 10889981048372: Thoraco-Lumbar 50mm Bone Screw (BFS-700-50-B)
• 10889981048365: Thoraco-Lumbar 45mm Bone Screw (BFS-700-45-B)
• 10889981048358: Thoraco-Lumbar 40mm Bone Screw (BFS-700-40-B)
• 10889981048341: Thoraco-Lumbar 35mm Bone Screw (BFS-700-35-B)
• 10889981048334: Thoraco-Lumbar 30mm Bone Screw (BFS-700-30-B)
• 10889981048327: Thoraco-Lumbar 25mm Bone Screw (BFS-700-25-B)
• 10889981048310: Thoraco-Lumbar 20mm Bone Screw (BFS-700-20-B)
• 10889981048303: Thoraco-Lumbar 117mm Plate (BFP-75-10-C)
• 10889981048297: Thoraco-Lumbar 112mm Plate (BFP-70-10-C)
• 10889981048280: Thoraco-Lumbar 107mm Plate (BFP-65-10-C)
• 10889981048273: Thoraco-Lumbar 102mm Plate (BFP-60-10-C)
• 10889981048266: Thoraco-Lumbar 97mm Plate (BFP-55-15-C)
• 10889981048259: Thoraco-Lumbar 92mm Plate (BFP-50-10-C)
• 10889981048242: Thoraco-Lumbar 88mm Plate (BFP-46-5-C)
• 10889981048235: Thoraco-Lumbar 84mm Plate (BFP-42-0-C)
• 10889981048228: Thoraco-Lumbar 80mm Plate (BFP-38-0-C)
• 10889981048211: Thoraco-Lumbar 77mm Plate (BFP-35-0-C)
• 10889981048204: Thoraco-Lumbar 74mm Plate (BFP-32-0-C)
• 10889981048198: Thoraco-Lumbar 71mm Plate (BFP-29-0-C)
• 10889981048181: Thoraco-Lumbar 69mm Plate (BFP-27-0-C)
• 10889981048174: Thoraco-Lumbar 67mm Plate (BFP-25-0-C)