TRESTLE ANTERIOR CERVICAL PLATING SYSTEM

GUDID 00844856000179

ANTERIOR CERVICAL PLATE, 1 LEVEL, SIZE 16

ALPHATEC SPINE, INC.

Orthopaedic fixation plate kit, non-bioabsorbable, sterile Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00844856000179
• NIH Device Record Key: fe3613b7-5fee-4350-9791-2825783031be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRESTLE ANTERIOR CERVICAL PLATING SYSTEM
• Version Model Number: 61001-016
• 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)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
• 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: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter
• Length: 16 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844856000179 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102820

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[00844856000179]

Moist Heat or Steam Sterilization

[00844856000179]

Moist Heat or Steam Sterilization

[00844856000179]

Moist Heat or Steam Sterilization

[00844856000179]

Moist Heat or Steam Sterilization

[00844856000179]

Moist Heat or Steam Sterilization

[00844856000179]

Moist Heat or Steam Sterilization

[00844856000179]

Moist Heat or Steam Sterilization

[00844856000179]

Moist Heat or Steam Sterilization

[00844856000179]

Moist Heat or Steam Sterilization

[00844856000179]

Moist Heat or Steam Sterilization

[00844856000179]

Moist Heat or Steam Sterilization

[00844856000179]

Moist Heat or Steam Sterilization

[00844856000179]

Moist Heat or Steam Sterilization

[00844856000179]

Moist Heat or Steam Sterilization

[00844856000179]

Moist Heat or Steam Sterilization

[00844856000179]

Moist Heat or Steam Sterilization

[00844856000179]

Moist Heat or Steam Sterilization

[00844856000179]

Moist Heat or Steam Sterilization

[00844856000179]

Moist Heat or Steam Sterilization

[00844856000179]

Moist Heat or Steam Sterilization

[00844856000179]

Moist Heat or Steam Sterilization

[00844856000179]

Moist Heat or Steam Sterilization

[00844856000179]

Moist Heat or Steam Sterilization

[00844856000179]

Moist Heat or Steam Sterilization

[00844856000179]

Moist Heat or Steam Sterilization

[00844856000179]

Moist Heat or Steam Sterilization

[00844856000179]

Moist Heat or Steam Sterilization

[00844856000179]

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: 2015-08-01

On-Brand Devices [TRESTLE ANTERIOR CERVICAL PLATING SYSTEM]

• 00844856099210: ANTERIOR CERVICAL PLATE, 2 LEVEL, SIZE 35
• 00844856001206: 4.5 SEMI CONSTRAINED SELF-TAPPING SCREW, 20mm
• 00844856001190: 4.5 SEMI CONSTRAINED SELF-TAPPING SCREW, 19mm
• 00844856001183: 4.5 SEMI CONSTRAINED SELF-TAPPING SCREW, 18mm
• 00844856001176: 4.5 SEMI CONSTRAINED SELF-TAPPING SCREW, 17mm
• 00844856001169: 4.5 SEMI CONSTRAINED SELF-TAPPING SCREW, 16mm
• 00844856001152: 4.5 SEMI CONSTRAINED SELF-TAPPING SCREW, 15mm
• 00844856001145: 4.5 SEMI CONSTRAINED SELF-TAPPING SCREW, 14mm
• 00844856001138: 4.5 SEMI CONSTRAINED SELF-TAPPING SCREW, 13mm
• 00844856001121: 4.5 SEMI CONSTRAINED SELF-TAPPING SCREW, 12mm
• 00844856001114: 4.5 SEMI CONSTRAINED SELF-TAPPING SCREW, 11mm
• 00844856001107: 4.5 SEMI CONSTRAINED SELF-TAPPING SCREW, 10mm
• 00844856001091: 4.0 SEMI CONSTRAINED SELF-TAPPING SCREW, 20mm
• 00844856001084: 4.0 SEMI CONSTRAINED SELF-TAPPING SCREW, 19mm
• 00844856001077: 4.0 SEMI CONSTRAINED SELF-TAPPING SCREW, 18mm
• 00844856001060: 4.0 SEMI CONSTRAINED SELF-TAPPING SCREW, 17mm
• 00844856001053: 4.0 SEMI CONSTRAINED SELF-TAPPING SCREW, 16mm
• 00844856001046: 4.0 SEMI CONSTRAINED SELF-TAPPING SCREW, 15mm
• 00844856001039: 4.0 SEMI CONSTRAINED SELF-TAPPING SCREW, 14mm
• 00844856001022: 4.0 SEMI CONSTRAINED SELF-TAPPING SCREW, 13mm
• 00844856001015: 4.0 SEMI CONSTRAINED SELF-TAPPING SCREW, 12mm
• 00844856001008: 4.0 SEMI CONSTRAINED SELF-TAPPING SCREW, 11mm
• 00844856000995: 4.0 SEMI CONSTRAINED SELF-TAPPING SCREW, 10mm
• 00844856000988: 4.0 SEMI CONSTRAINED SELF-DRILLING SCREW, 20mm
• 00844856000971: 4.0 SEMI CONSTRAINED SELF-DRILLING SCREW, 19mm
• 00844856000964: 4.0 SEMI CONSTRAINED SELF-DRILLING SCREW, 18mm
• 00844856000957: 4.0 SEMI CONSTRAINED SELF-DRILLING SCREW, 17mm
• 00844856000940: 4.0 SEMI CONSTRAINED SELF-DRILLING SCREW, 16mm
• 00844856000933: 4.0 SEMI CONSTRAINED SELF-DRILLING SCREW, 15mm
• 00844856000926: 4.0 SEMI CONSTRAINED SELF-DRILLING SCREW, 14mm
• 00844856000919: 4.0 SEMI CONSTRAINED SELF-DRILLING SCREW, 13mm
• 00844856000902: 4.0 SEMI CONSTRAINED SELF-DRILLING SCREW, 12mm
• 00844856000896: 4.0 SEMI CONSTRAINED SELF-DRILLING SCREW, 11mm
• 00844856000889: 4.0 SEMI CONSTRAINED SELF-DRILLING SCREW, 10mm
• 00844856000872: 4.5 VARIABLE ANGLE SELF-TAPPING SCREW, 20mm
• 00844856000865: 4.5 VARIABLE ANGLE SELF-TAPPING SCREW, 19mm
• 00844856000858: 4.5 VARIABLE ANGLE SELF-TAPPING SCREW, 18mm
• 00844856000841: 4.5 VARIABLE ANGLE SELF-TAPPING SCREW, 17mm
• 00844856000834: 4.5 VARIABLE ANGLE SELF-TAPPING SCREW, 16mm
• 00844856000827: 4.5 VARIABLE ANGLE SELF-TAPPING SCREW, 15mm
• 00844856000810: 4.5 VARIABLE ANGLE SELF-TAPPING SCREW, 14mm
• 00844856000803: 4.5 VARIABLE ANGLE SELF-TAPPING SCREW, 13mm
• 00844856000797: 4.5 VARIABLE ANGLE SELF-TAPPING SCREW, 12mm
• 00844856000780: 4.5 VARIABLE ANGLE SELF-TAPPING SCREW, 11mm
• 00844856000773: 4.5 VARIABLE ANGLE SELF-TAPPING SCREW, 10mm
• 00844856000766: 4.0 VARIABLE ANGLE SELF-TAPPING SCREW, 20mm
• 00844856000759: 4.0 VARIABLE ANGLE SELF-TAPPING SCREW, 19mm
• 00844856000742: 4.0 VARIABLE ANGLE SELF-TAPPING SCREW, 18mm
• 00844856000735: 4.0 VARIABLE ANGLE SELF-TAPPING SCREW, 17mm
• 00844856000728: 4.0 VARIABLE ANGLE SELF-TAPPING SCREW, 16mm