Intervertebral Body Fusion Device 50-0004

GUDID 00840019925099

AccuFit™ RP System Case (Empty)

PRECISION SPINE, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00840019925099
• NIH Device Record Key: da65de9a-0516-4efb-bb43-8b223bbf1225
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intervertebral Body Fusion Device
• Version Model Number: 50-0004
• Catalog Number: 50-0004
• Company DUNS: 079398589
• Company Name: PRECISION 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: false
• Lot Batch: false
• 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	00840019925099 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092193

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00840019925099]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-04
• Device Publish Date: 2019-03-27

On-Brand Devices [Intervertebral Body Fusion Device ]

• 00840019925105: Tray
• 00840019925099: AccuFit™ RP System Case (Empty)
• 00840019925075: Straight Awl ALIF Stabilizer
• 00840019925068: Install Guide ALIF Stabilizer 17mm
• 00840019925051: Install Guide ALIF Stabilizer 15mm
• 00840019925044: Install Guide ALIF Stabilizer 13mm
• 00840019925037: Install Guide ALIF Stabilizer 11mm
• 00840019925013: Universal Driver ALIF Stabilizer 3.25mm
• 00840019925006: Awl Fixed 30 degree ALIF Stabilizer
• 00840019924986: ShurFit™ ALIF Implant Case # 3 (Empty)
• 00840019924979: ShurFit™ ALIF Implant Case # 2 (Empty)
• 00840019924962: ShurFit™ ALIF Implant Case # 1 (Empty)
• 00840019924955: ShurFit™ ALIF Instrument Case # 3 (Empty)
• 00840019924948: ShurFit™ ALIF Instrument Case # 2 (Empty)
• 00840019924924: ALIF Sizer 15 degree 21mm x 39mm
• 00840019924917: ALIF Sizer 15 degree 19mm x 39mm
• 00840019924900: ALIF Sizer 15 degree 17mm x 39mm
• 00840019924894: ALIF Sizer 15 degree 15mm x 39mm
• 00840019924887: ALIF Sizer 15 degree 13mm x 39mm
• 00840019924863: ALIF Sizer 8 degree 21mm x 39mm
• 00840019924849: ALIF Sizer 8 degree 17mm x 39mm
• 00840019924832: ALIF Sizer 8 degree 15mm x 39mm
• 00840019924818: ALIF Sizer 8 degree 11mm x 39mm
• 00840019924795: ALIF Sizer 15 degree 21mm x 32mm
• 00840019924788: ALIF Sizer 15 degree 19mm x 32mm
• 00840019924764: ALIF Sizer 15 degree 15mm x 32mm
• 00840019924757: ALIF Sizer 15 degree 13mm x 32mm
• 00840019924740: ALIF Sizer 15 degree 11mm x 32mm
• 00840019924726: ALIF Sizer 8 degree 19mm x 32mm
• 00840019924719: ALIF Sizer 8 degree 17mm x 32mm
• 00840019924702: ALIF Sizer 8 degree 15mm x 32mm
• 00840019924696: ALIF Sizer 8 degree 13mm x 32mm
• 00840019924689: ALIF Sizer 8 degree 11mm x 32mm
• 00840019924672: ALIF Sizer 8 degree 9mm x 32mm
• 00840019924658: ALIF Sizer 15 degree 21mm x 26mm
• 00840019924641: ALIF Sizer 15 degree 19mm x 26mm
• 00840019924627: ALIF Sizer 15 degree 15mm x 26mm
• 00840019924610: ALIF Sizer 15 degree 13mm x 26mm
• 00840019924597: 00-901608-21
• 00840019924580: ALIF Sizer 8 degree 19mm x 26mm
• 00840019924573: ALIF Sizer 8 degree 17mm x 26mm
• 00840019924566: ALIF Sizer 8 degree 15mm x 26mm
• 00840019924559: ALIF Sizer 8 degree 13mm x 26mm
• 00840019924542: ALIF Sizer 8 degree 11mm x 26mm
• 00840019924528: Volt Inserter Gator Intech Green
• 00840019924511: Rongeur
• 00840019924504: Distractor
• 00840019924481: Curette
• 00840019924474: Curette
• 00840019924450: Curette