ASCENDANT

GUDID 00840996184250

ASCENDANT,TRIAL-RASP,LR,NS,12X14X8

Choice Spine, LP

Polymeric spinal interbody fusion cage

• Primary Device ID: 00840996184250
• NIH Device Record Key: 93311877-6d4a-475c-b645-e7395e8d4849
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASCENDANT
• Version Model Number: 05-099-31-1408N
• Company DUNS: 078293017
• Company Name: Choice Spine, LP
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996184250 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141129

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

[00840996184250]

Moist Heat or Steam Sterilization

[00840996184250]

Moist Heat or Steam Sterilization

[00840996184250]

Moist Heat or Steam Sterilization

[00840996184250]

Moist Heat or Steam Sterilization

[00840996184250]

Moist Heat or Steam Sterilization

[00840996184250]

Moist Heat or Steam Sterilization

[00840996184250]

Moist Heat or Steam Sterilization

[00840996184250]

Moist Heat or Steam Sterilization

[00840996184250]

Moist Heat or Steam Sterilization

[00840996184250]

Moist Heat or Steam Sterilization

[00840996184250]

Moist Heat or Steam Sterilization

[00840996184250]

Moist Heat or Steam Sterilization

[00840996184250]

Moist Heat or Steam Sterilization

[00840996184250]

Moist Heat or Steam Sterilization

[00840996184250]

Moist Heat or Steam Sterilization

[00840996184250]

Moist Heat or Steam Sterilization

[00840996184250]

Moist Heat or Steam Sterilization

[00840996184250]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-14
• Device Publish Date: 2023-07-06

On-Brand Devices [ASCENDANT]

• 00840996184373: ASCENDANT,TRIAL-RASP,LR,NS,14X16X12
• 00840996184366: ASCENDANT,TRIAL-RASP,LR,NS,14X16X11
• 00840996184359: ASCENDANT,TRIAL-RASP,LR,NS,14X16X10
• 00840996184342: ASCENDANT,TRIAL-RASP,LR,NS,14X16X9
• 00840996184335: ASCENDANT,TRIAL-RASP,LR,NS,14X16X8
• 00840996184328: ASCENDANT,TRIAL-RASP,LR,NS,14X16X7
• 00840996184311: ASCENDANT,TRIAL-RASP,LR,NS,14X16X6
• 00840996184304: ASCENDANT,TRIAL-RASP,LR,NS,14X16X5
• 00840996184298: ASCENDANT,TRIAL-RASP,LR,NS,12X14X12
• 00840996184281: ASCENDANT,TRIAL-RASP,LR,NS,12X14X11
• 00840996184274: ASCENDANT,TRIAL-RASP,LR,NS,12X14X10
• 00840996184267: ASCENDANT,TRIAL-RASP,LR,NS,12X14X9
• 00840996184250: ASCENDANT,TRIAL-RASP,LR,NS,12X14X8
• 00840996184243: ASCENDANT,TRIAL-RASP,LR,NS,12X14X7
• 00840996157230: ASCENDANT, GRAFT LOADING BLOCK
• 00840996157223: ASCENDANT, GAUGE BLOCK
• 00840996153768: ASCENDANT, INSERTER
• 00840996153737: ASCENDANT, INSERTER, LOCK SHAFT
• 00840996153720: ASCENDANT, INSERTER, SMALL
• 00840996153713: ASCENDANT, TAMP W/2MM STOP, RECT
• 00840996153706: ASCENDANT, TAMP W/O STOP, RECT
• 00840996153690: ASCENDANT, TAMP W/2MM STOP
• 00840996153683: ASCENDANT, PROBE, HOOKED
• 00840996153676: ASCENDANT, TAMP W/O STOP