BridgePoint Spinous Process Fixation System

GUDID 00844856059191

Spinous Process Clamp Assembly, Large, 45-50mm

ALPHATEC SPINE, INC.

Orthopaedic fixation plate kit, non-bioabsorbable, sterile Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant

• Primary Device ID: 00844856059191
• NIH Device Record Key: 0e00361c-e148-400b-b64e-90958f6d8733
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BridgePoint Spinous Process Fixation System
• Version Model Number: 24001-145
• 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: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844856059191 [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

[00844856059191]

Moist Heat or Steam Sterilization

[00844856059191]

Moist Heat or Steam Sterilization

[00844856059191]

Moist Heat or Steam Sterilization

[00844856059191]

Moist Heat or Steam Sterilization

[00844856059191]

Moist Heat or Steam Sterilization

[00844856059191]

Moist Heat or Steam Sterilization

[00844856059191]

Moist Heat or Steam Sterilization

[00844856059191]

Moist Heat or Steam Sterilization

[00844856059191]

Moist Heat or Steam Sterilization

[00844856059191]

Moist Heat or Steam Sterilization

[00844856059191]

Moist Heat or Steam Sterilization

[00844856059191]

Moist Heat or Steam Sterilization

[00844856059191]

Moist Heat or Steam Sterilization

[00844856059191]

Moist Heat or Steam Sterilization

[00844856059191]

Moist Heat or Steam Sterilization

[00844856059191]

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