ASCENDANT

GUDID 00840996184373

ASCENDANT,TRIAL-RASP,LR,NS,14X16X12

Choice Spine, LP

Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage

• Primary Device ID: 00840996184373
• NIH Device Record Key: c2b035c0-b7e3-4fab-ac25-e7df1f7de37c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASCENDANT
• Version Model Number: 05-099-31-1612N
• 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	00840996184373 [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

[00840996184373]

Moist Heat or Steam Sterilization

[00840996184373]

Moist Heat or Steam Sterilization

[00840996184373]

Moist Heat or Steam Sterilization

[00840996184373]

Moist Heat or Steam Sterilization

[00840996184373]

Moist Heat or Steam Sterilization

[00840996184373]

Moist Heat or Steam Sterilization

[00840996184373]

Moist Heat or Steam Sterilization

[00840996184373]

Moist Heat or Steam Sterilization

[00840996184373]

Moist Heat or Steam Sterilization

[00840996184373]

Moist Heat or Steam Sterilization

[00840996184373]

Moist Heat or Steam Sterilization

[00840996184373]

Moist Heat or Steam Sterilization

[00840996184373]

Moist Heat or Steam Sterilization

[00840996184373]

Moist Heat or Steam Sterilization

[00840996184373]

Moist Heat or Steam Sterilization

[00840996184373]

Moist Heat or Steam Sterilization

[00840996184373]

Moist Heat or Steam Sterilization

[00840996184373]

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