AMP II

GUDID 00190376706801

AMP II PLATE AND CENTER SCREW, 1-HOLE 08

ALPHATEC SPINE, INC.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00190376706801
• NIH Device Record Key: bf617ecb-9c2c-414f-a01f-59710c1a24b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMP II
• Version Model Number: 616-1-08-S
• Company DUNS: 602465783
• Company Name: ALPHATEC SPINE, INC.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com

Device Dimensions

• Length: 19 Millimeter
• Width: 11 Millimeter
• Length: 19 Millimeter
• Width: 11 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376706801 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242364

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-26
• Device Publish Date: 2026-02-18

On-Brand Devices [AMP II]

• 00190376649597: Bone Screwdriver, Stab n Grab Offset
• 00190376643267: Implant Guide Clip, LTP
• 00190376635538: AMP II Plate and Center Screw, 2-Hole, 10
• 00190376635521: AMP II Plate and Center Screw, 2-Hole, 08
• 00190376635514: AMP II Plate and Center Screw, 2-Hole, 06
• 00190376635507: AMP II Plate and Center Screw, 2-Hole, 04
• 00190376635484: AMP II Plate and Center Screw, 1-Hole, 10
• 00190376635477: AMP II Plate and Center Screw, 1-Hole, 08
• 00190376635460: AMP II Plate and Center Screw, 1-Hole, 06
• 00190376635453: AMP II Plate and Center Screw, 1-Hole, 04
• 00190376610467: AMP II Removal Tool
• 00190376588582: Bone Screwdriver, Active
• 00190376588575: Awl, Offset
• 00190376588551: Implant Guide Clip, PTP
• 00190376588544: AMP II Center Screw Driver, Short
• 00190376588537: AMP II Center Screw Driver, Ball Hex
• 00190376588520: AMP II In-Situ Inserter, C/C
• 00190376588513: AMP II In-Situ Inserter
• 00190376588506: AMP II Inserter Sleeve, M/L
• 00190376588490: AMP II Inserter Sleeve, C/C
• 00190376588483: AMP II Inserter Sleeve
• 00190376709253: Lateral Plating Drill, Adjustable
• 00190376709246: Lateral Plating Awl, Adjustable
• 00190376709239: AMP II In-Situ Inserter, C/C Right
• 00190376709222: AMP II In-Situ Inserter, C/C Left
• 00190376709215: AMP II Inserter Sleeve, C/C Right
• 00190376709208: AMP II Inserter Sleeve, C/C Left
• 00190376706870: AMP II PLATE AND CENTER SCREW, 2-HOLE 12
• 00190376706863: AMP II PLATE AND CENTER SCREW, 2-HOLE 10
• 00190376706856: AMP II PLATE AND CENTER SCREW, 2-HOLE 08
• 00190376706849: AMP II PLATE AND CENTER SCREW, 2-HOLE 06
• 00190376706832: AMP II PLATE AND CENTER SCREW, 2-HOLE 04
• 00190376706825: AMP II PLATE AND CENTER SCREW, 1-HOLE 12
• 00190376706818: AMP II PLATE AND CENTER SCREW, 1-HOLE 10
• 00190376706801: AMP II PLATE AND CENTER SCREW, 1-HOLE 08
• 00190376706795: AMP II PLATE AND CENTER SCREW, 1-HOLE 06
• 00190376706788: AMP II PLATE AND CENTER SCREW, 1-HOLE 04