TRESTLE LUXE

GUDID 00190376215235

TRESTLE LUXE II, ACP, 2-LEVEL, 38

ALPHATEC SPINE, INC.

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: 00190376215235
• NIH Device Record Key: d943fcf2-34fd-423c-8c42-2eda9a7bc4c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRESTLE LUXE
• Version Model Number: 711-0238
• 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

Device Dimensions

• Height: 38 Millimeter
• Height: 38 Millimeter
• Height: 38 Millimeter
• Height: 38 Millimeter
• Height: 38 Millimeter
• Height: 38 Millimeter
• Height: 38 Millimeter
• Height: 38 Millimeter
• Height: 38 Millimeter
• Height: 38 Millimeter
• Height: 38 Millimeter
• Height: 38 Millimeter
• Height: 38 Millimeter
• Height: 38 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376215235 [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

[00190376215235]

Moist Heat or Steam Sterilization

[00190376215235]

Moist Heat or Steam Sterilization

[00190376215235]

Moist Heat or Steam Sterilization

[00190376215235]

Moist Heat or Steam Sterilization

[00190376215235]

Moist Heat or Steam Sterilization

[00190376215235]

Moist Heat or Steam Sterilization

[00190376215235]

Moist Heat or Steam Sterilization

[00190376215235]

Moist Heat or Steam Sterilization

[00190376215235]

Moist Heat or Steam Sterilization

[00190376215235]

Moist Heat or Steam Sterilization

[00190376215235]

Moist Heat or Steam Sterilization

[00190376215235]

Moist Heat or Steam Sterilization

[00190376215235]

Moist Heat or Steam Sterilization

[00190376215235]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-14
• Device Publish Date: 2019-11-06

On-Brand Devices [TRESTLE LUXE]

• 00844856001398: FIXED 2.3MM DRILL BIT, 20MM
• 00844856001374: FIXED 2.3MM DRILL BIT, 18MM
• 00844856001350: FIXED 2.3MM DRILL BIT, 16MM
• 00844856001336: FIXED 2.3MM DRILL BIT, 14MM
• 00844856001312: FIXED 2.3MM DRILL BIT, 12MM
• 00844856001299: FIXED 2.3MM DRILL BIT, 10MM
• 00840967192697: TEMPORARY FIXATION PIN
• 00190376233765: TRESTLE LUXE II, ACP, 1-LEVEL, 18
• 00190376220093: TEMPORARY FIXATION PIN
• 00190376217819: 4.0MM VARIABLE ANGLE, SELF-TAPPING SCREW, 21 MM
• 00190376217802: 4.0MM VARIABLE ANGLE, SELF-TAPPING SCREW, 20 MM
• 00190376217796: 4.0MM VARIABLE ANGLE, SELF-TAPPING SCREW, 19 MM
• 00190376217789: 4.0MM VARIABLE ANGLE, SELF-TAPPING SCREW, 18 MM
• 00190376217772: 4.0MM VARIABLE ANGLE, SELF-TAPPING SCREW, 17 MM
• 00190376217765: 4.0MM VARIABLE ANGLE, SELF-TAPPING SCREW, 16 MM
• 00190376217758: 4.0MM VARIABLE ANGLE, SELF-TAPPING SCREW, 15 MM
• 00190376217741: 4.0MM VARIABLE ANGLE, SELF-TAPPING SCREW, 14 MM
• 00190376217734: 4.0MM VARIABLE ANGLE, SELF-TAPPING SCREW, 13 MM
• 00190376217727: 4.0MM VARIABLE ANGLE, SELF-TAPPING SCREW, 12 MM
• 00190376217710: 4.0MM VARIABLE ANGLE, SELF-TAPPING SCREW, 11 MM
• 00190376217703: 4.0MM VARIABLE ANGLE, SELF-TAPPING SCREW, 10 MM
• 00190376217697: 4.5MM FIXED ANGLE, SELF-DRILLING SCREW, 24 MM
• 00190376217680: 4.5MM FIXED ANGLE, SELF-DRILLING SCREW, 23 MM
• 00190376217673: 4.5MM FIXED ANGLE, SELF-DRILLING SCREW, 22 MM
• 00190376217666: 4.5MM FIXED ANGLE, SELF-DRILLING SCREW, 21 MM
• 00190376217659: 4.5MM FIXED ANGLE, SELF-DRILLING SCREW, 20 MM
• 00190376217642: 4.5MM FIXED ANGLE, SELF-DRILLING SCREW, 19 MM
• 00190376217635: 4.5MM FIXED ANGLE, SELF-DRILLING SCREW, 18 MM
• 00190376217628: 4.5MM FIXED ANGLE, SELF-DRILLING SCREW, 17 MM
• 00190376217611: 4.5MM FIXED ANGLE, SELF-DRILLING SCREW, 16 MM
• 00190376217604: 4.5MM FIXED ANGLE, SELF-DRILLING SCREW, 15 MM
• 00190376217598: 4.5MM FIXED ANGLE, SELF-DRILLING SCREW, 14 MM
• 00190376217581: 4.5MM FIXED ANGLE, SELF-DRILLING SCREW, 13 MM
• 00190376217574: 4.5MM FIXED ANGLE, SELF-DRILLING SCREW, 12 MM
• 00190376217567: 4.5MM FIXED ANGLE, SELF-DRILLING SCREW, 11 MM
• 00190376217550: 4.5MM FIXED ANGLE, SELF-DRILLING SCREW, 10 MM
• 00190376217543: 4.0MM FIXED ANGLE, SELF-DRILLING SCREW, 24 MM
• 00190376217536: 4.0MM FIXED ANGLE, SELF-DRILLING SCREW, 23 MM
• 00190376217529: 4.0MM FIXED ANGLE, SELF-DRILLING SCREW, 22 MM
• 00190376217512: 4.0MM FIXED ANGLE, SELF-DRILLING SCREW, 21 MM
• 00190376217505: 4.0MM FIXED ANGLE, SELF-DRILLING SCREW, 20 MM
• 00190376217499: 4.0MM FIXED ANGLE, SELF-DRILLING SCREW, 19 MM
• 00190376217482: 4.0MM FIXED ANGLE, SELF-DRILLING SCREW, 18 MM
• 00190376217475: 4.0MM FIXED ANGLE, SELF-DRILLING SCREW, 17 MM
• 00190376217468: 4.0MM FIXED ANGLE, SELF-DRILLING SCREW, 16 MM
• 00190376217451: 4.0MM FIXED ANGLE, SELF-DRILLING SCREW, 15 MM
• 00190376217444: 4.0MM FIXED ANGLE, SELF-DRILLING SCREW, 14 MM
• 00190376217437: 4.0MM FIXED ANGLE, SELF-DRILLING SCREW, 13 MM
• 00190376217420: 4.0MM FIXED ANGLE, SELF-DRILLING SCREW, 12 MM
• 00190376217413: 4.0MM FIXED ANGLE, SELF-DRILLING SCREW, 11 MM