BridgePoint Spinous Process Fixation System

GUDID 00844856059177

Spinous Process Clamp Assembly, Small, 35-40mm

ALPHATEC SPINE, INC.

Orthopaedic fixation plate kit, non-bioabsorbable, sterile

• Primary Device ID: 00844856059177
• NIH Device Record Key: 38503ce1-db6d-459a-9db5-b64766511a5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BridgePoint Spinous Process Fixation System
• Version Model Number: 24001-135
• Company DUNS: 602465783
• Company Name: ALPHATEC SPINE, INC.
• Device Count: 1
• DM Exempt: true
• 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)494-6840
• Email: mfunk@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com

Device Dimensions

• Length: 35 Millimeter
• Length: 35 Millimeter
• Length: 35 Millimeter
• Length: 35 Millimeter
• Length: 35 Millimeter
• Length: 35 Millimeter
• Length: 35 Millimeter
• Length: 35 Millimeter
• Length: 35 Millimeter
• Length: 35 Millimeter
• Length: 35 Millimeter
• Length: 35 Millimeter
• Length: 35 Millimeter
• Length: 35 Millimeter
• Length: 35 Millimeter
• Length: 35 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844856059177 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103205

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[00844856059177]

Moist Heat or Steam Sterilization

[00844856059177]

Moist Heat or Steam Sterilization

[00844856059177]

Moist Heat or Steam Sterilization

[00844856059177]

Moist Heat or Steam Sterilization

[00844856059177]

Moist Heat or Steam Sterilization

[00844856059177]

Moist Heat or Steam Sterilization

[00844856059177]

Moist Heat or Steam Sterilization

[00844856059177]

Moist Heat or Steam Sterilization

[00844856059177]

Moist Heat or Steam Sterilization

[00844856059177]

Moist Heat or Steam Sterilization

[00844856059177]

Moist Heat or Steam Sterilization

[00844856059177]

Moist Heat or Steam Sterilization

[00844856059177]

Moist Heat or Steam Sterilization

[00844856059177]

Moist Heat or Steam Sterilization

[00844856059177]

Moist Heat or Steam Sterilization

[00844856059177]

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: 2015-08-31

On-Brand Devices [BridgePoint Spinous Process Fixation System]

• 00844856059191: Spinous Process Clamp Assembly, Large, 45-50mm
• 00844856059184: Spinous Process Clamp Assembly, Medium, 40-45mm
• 00844856059177: Spinous Process Clamp Assembly, Small, 35-40mm