Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)

GUDID 00840996138246

PLI,TRIAL,SHARK,9,28X12,0 DEG

Choice Spine, LP

Polymeric spinal interbody fusion cage

• Primary Device ID: 00840996138246
• NIH Device Record Key: 82a880bb-4641-4cba-91cf-8dd3521ed352
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)
• Version Model Number: P072-28120
• 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

Customer Support Contacts

• Phone: +1(865)246-3333
• Email: info@choicespine.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996138246 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140142

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[00840996138246]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-07-29

On-Brand Devices [Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)]

• 00840996171144: PLI,PARALLEL,PADDLE,SHAVER,7X3.25
• 00840996147897: SPCL,DISTRACTOR,18
• 00840996147880: SPCL,DISTRACTOR,17
• 00840996147873: SPCL,DISTRACTOR,16
• 00840996147866: SPCL,DISTRACTOR,15
• 00840996147859: SPCL,DISTRACTOR,13
• 00840996147842: SPCL,DISTRACTOR,12
• 00840996147835: SPCL,DISTRACTOR,11
• 00840996147828: SPCL,DISTRACTOR,10
• 00840996147811: SPCL,DISTRACTOR,9
• 00840996147804: SPCL,DISTRACTOR,8
• 00840996147798: SPCL,DISTRACTOR,7
• 00840996147781: PLI,SPCL,CURETTE,ANGLED,UP
• 00840996147774: PLI,SPCL,CURETTE,ANGLED,DOWN
• 00840996147767: PLI,SPCL,RASP,DOUBLE SIDED,12MM
• 00840996147750: PLI,SPCL,PADDLE SHAVER, PARALLEL,18H
• 00840996147743: PLI,SPCL,PADDLE SHAVER, PARALLEL,17H
• 00840996147736: PLI,SPCL,PADDLE SHAVER, PARALLEL,16H
• 00840996147729: PLI,SPCL,PADDLE SHAVER, PARALLEL,15H
• 00840996147712: PLI,SPCL,PADDLE SHAVER, PARALLEL,14H
• 00840996147705: PLI,SPCL,PADDLE SHAVER, PARALLEL,13H
• 00840996147699: PLI,SPCL,PADDLE SHAVER, PARALLEL,12H
• 00840996147682: PLI,SPCL,PADDLE SHAVER, PARALLEL,11H
• 00840996147675: PLI,SPCL,PADDLE SHAVER, PARALLEL,10H
• 00840996147668: PLI,SPCL,PADDLE SHAVER, PARALLEL,9H
• 00840996147651: PLI,SPCL,PADDLE SHAVER, PARALLEL,8H
• 00840996147644: PLI,SPCL,PADDLE SHAVER, PARALLEL,7H
• 00840996147637: PLI,SPCL,TRIAL,8mmH
• 00840996147620: PLI,SPCL,TRIAL,7H
• 00840996147613: PLI,SPCL, TAMP, ANGLED, 9mmW
• 00840996147606: PLI,SPCL,TAMP, 9mm W
• 00840996147590: PLI,SPCL,TAMP, ANGLED,10.5mm
• 00840996147583: PLI,SPCL,TAMP, 10.5mm
• 00840996147576: SPCL,PLI,BONE GRAFT FUNNEL,NO WINDOWS
• 00840996147569: SPCL,PLI,INSERTER
• 00840996147552: PLI, SPECIAL TAMP
• 00840996147545: SPCL,HARPOON,TAMP W/ ARM
• 00840996147538: SPCL,HARPOON,TAMP W/ TEETH
• 00840996147521: PLI,SPCL,CURETTE,ANGLED
• 00840996147514: PLI,SPCL,CURETTE,STRAIGHT
• 00840996147507: PLI,SPCL,RASP,ANGLED
• 00840996147491: PLI,SPCL,RASP,STRAIGHT
• 00840996147484: #2 CURETTE, ANGLED, SPECIAL
• 00840996147477: SPCL,PLI,BONE PLUNGER,SHORT
• 00840996147460: SPCL,PLI,BONE PLUNGER,LONG
• 00840996147453: NERVE ROOT RETRACTOR, SPECIAL
• 00840996147446: SPCL,PLI,SLAP HAMMER
• 00840996147439: SPCL,PLI,INSERTER
• 00840996147422: SPCL,PLI,MUTLITOOL
• 00840996147415: SPCL,BONE GRAFT PLUNGER