Contact ALP

GUDID 00840311232710

6.5 X 28 Rescue Screw Assembly

Surgalign Spine Technologies, Inc.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00840311232710
• NIH Device Record Key: 72299ec9-8a09-4244-a3cc-a00d366b5130
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Contact ALP
• Version Model Number: 25-65-28
• Company DUNS: 014520584
• Company Name: Surgalign Spine Technologies, 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(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840311232710 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090222

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

[00840311232710]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-19
• Device Publish Date: 2023-06-09

On-Brand Devices [Contact ALP]

• 00840311233151: 54mm Anterior Sacral Plate
• 00840311233144: 52mm Anterior Sacral Plate
• 00840311233137: 50mm Anterior Sacral Plate
• 00840311233120: 48mm Anterior Sacral Plate
• 00840311233113: 46mm Anterior Sacral Plate
• 00840311233106: 44mm Anterior Sacral Plate
• 00840311233090: 42mm Anterior Sacral Plate
• 00840311233083: 40mm Anterior Sacral Plate
• 00840311233076: 38mm Anterior Sacral Plate
• 00840311233069: 36mm Anterior Sacral Plate
• 00840311233052: 34mm Anterior Sacral Plate
• 00840311232970: 54mm Anterior Lumbar Plate
• 00840311232963: 52mm Anterior Lumbar Plate
• 00840311232956: 50mm Anterior Lumbar Plate
• 00840311232949: 48mm Anterior Lumbar Plate
• 00840311232932: 46mm Anterior Lumbar Plate
• 00840311232925: 44mm Anterior Lumbar Plate
• 00840311232918: 42mm Anterior Lumbar Plate
• 00840311232901: 40mm Anterior Lumbar Plate
• 00840311232895: 38mm Anterior Lumbar Plate
• 00840311232888: 36mm Anterior Lumbar Plate
• 00840311232871: 34mm Anterior Lumbar Plate
• 00840311232772: 6.5 X 40 Rescue Screw Assembly
• 00840311232765: 6.5 X 38 Rescue Screw Assembly
• 00840311232758: 6.5 X 36 Rescue Screw Assembly
• 00840311232741: 6.5 X 34 Rescue Screw Assembly
• 00840311232734: 6.5 X 32 Rescue Screw Assembly
• 00840311232727: 6.5 X 30 Rescue Screw Assembly
• 00840311232710: 6.5 X 28 Rescue Screw Assembly
• 00840311232703: 6.5 X 26 Rescue Screw Assembly
• 00840311232697: 6.5 X 24 Rescue Screw Assembly
• 00840311232680: 6.5 X 22 Rescue Screw Assembly
• 00840311232673: 6.0 X 40 Lumbar Screw Assembly
• 00840311232666: 6.0 X 38 Lumbar Screw Assembly
• 00840311232659: 6.0 X 36 Lumbar Screw Assembly
• 00840311232642: 6.0 X 34 Lumbar Screw Assembly
• 00840311232635: 6.0 X 32 Lumbar Screw Assembly
• 00840311232628: 6.0 X 30 Lumbar Screw Assembly
• 00840311232611: 6.0 X 28 Lumbar Screw Assembly
• 00840311232604: 6.0 X 26 Lumbar Screw Assembly
• 00840311232598: 6.0 X 24 Lumbar Screw Assembly
• 00840311232581: 6.0 X 22 Lumbar Screw Assembly
• 00840311233243: Contact ALP, Threaded Screw Inserter
• 00840311233182: Torque Limiting Handle, 1/4" Hex Drive
• 00840311233175: Tightener
• 00840311233021: RATCHETING T-HANDLE, 1/4" SQUARE DRIVE
• 00840311232987: Palm Handle, 1/4" Square Drive
• 00840311232864: Locker
• 00840311232857: Inserter
• 00840311232840: Holder