Acapella One

GUDID 00840996150811

ACAPELLA,TRIAL,LR,NS,14X16X10

Choice Spine, LP

Polymeric spinal interbody fusion cage

• Primary Device ID: 00840996150811
• NIH Device Record Key: 1f756b11-9d2a-47e1-beb2-20e341487a8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acapella One
• Version Model Number: 05-099-05-1610
• Company DUNS: 078293017
• Company Name: Choice Spine, LP
• 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: 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	00840996150811 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132582

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

[00840996150811]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-04
• Device Publish Date: 2024-02-24

On-Brand Devices [Acapella One]

• 00840996170291: ACAPELLA,TRIAL,RASP,PA,WS,14X16X4
• 00840996170284: ACAPELLA,TRIAL,RASP,PA,WS,12X14X4
• 00840996170277: ACAPELLA,TRIAL,RASP,LR,WS,12X14X4
• 00840996153263: ACAPELLA,INSERTER, INNER WEDGE
• 00840996153256: ACAPELLA,INSERTER
• 00840996153065: ACAPELLA,INSERTER,STANDARD
• 00840996153058: ACAPELLA,INSERTER
• 00840996153041: ACAPELLA,SINGLE IMPACTOR
• 00840996153034: ACAPELLA,SINGLE IMPACTOR
• 00840996153027: ACAPELLA,INSERTER SHAFT V2
• 00840996153003: ACAPELLA,CUP CURETTE 2/0
• 00840996152990: ACAPELLA,FINAL LOCKING TOOL
• 00840996152983: ACAPELLA,MALLET
• 00840996152976: ACAPELLA,CURETTE,ANGLED RING,NRL
• 00840996152969: ACAPELLA,CURETTE,ANGLED RING
• 00840996152952: ACAPELLA,CURETTE,STR RING,NRL
• 00840996152945: ACAPELLA,CURETTE,STRT RING
• 00840996152938: ACAPELLA,DOMED RASP W/ STOP
• 00840996152921: ACAPELLA,DOMED RASP NO STOP
• 00840996152914: ACAPELLA,ANGLE RASP W/S KNURL
• 00840996152907: ACAPELLA,ANGLE RASP N/S KNURL
• 00840996152891: ACAPELLA,ANGLED RASP W/ STOP
• 00840996152884: ACAPELLA,ANGLED RASP NO STOP
• 00840996152877: ACAPELLA,RASP W/S KNURL HNDLE
• 00840996152860: ACAPELLA,RASP N/S KNURL HNDLE
• 00840996152853: ACAPELLA,RASP W/ STOP
• 00840996152846: ACAPELLA,RASP,NO STOP
• 00840996152839: ACAPELLA,A1 ANCHOR REMOVAL
• 00840996152822: ACAPELLA,DISTRACTOR,SM,14X16
• 00840996152815: ACAPELLA,DISTRACTR 14X16
• 00840996152808: ACAPELLA,DISTRACTOR,SM,12X14
• 00840996152792: ACAPELLA,DISTRACTR,12X14
• 00840996152785: ACAPELLA,SHORT DBL IMPACT V2
• 00840996152778: ACAPELLA,SHORT DBL IMPACT V2
• 00840996152761: ACAPELLA,TRIAL,CX,WS,14X18X12
• 00840996152754: ACAPELLA,TRIAL,CX,WS,14X18X11
• 00840996152747: ACAPELLA,TRIAL,CX,WS,14X18X10
• 00840996152730: ACAPELLA,TRIAL,CX,WS,14X18X9
• 00840996152723: ACAPELLA,TRIAL,CX,WS,14X18X8
• 00840996152716: ACAPELLA,TRIAL,CX,WS,14X18X7
• 00840996152709: ACAPELLA,TRIAL,CX,WS,14X18X6
• 00840996152693: ACAPELLA,TRIAL,CX,WS,14X18X5
• 00840996152686: ACAPELLA,TRIAL,CX,WS,14X18X4
• 00840996152679: ACAPELLA,TRIAL,CX,WS,14X16X12
• 00840996152662: ACAPELLA,TRIAL,CX,WS,14X16X11
• 00840996152655: ACAPELLA,TRIAL,DM,WS,14X16X10
• 00840996152648: ACAPELLA,TRIAL,DM,WS,14X16X9
• 00840996152631: ACAPELLA,TRIAL,DM,WS,14X16X8
• 00840996152624: ACAPELLA,TRIAL,DM,WS,14X16X7
• 00840996152617: ACAPELLA,TRIAL,DM,WS,14X16X6