AccelFix Spinal Fixation System

GUDID 08800061323597

Mono Axial Screw Ø8.5 , 115mm

L&K BIOMED CO. ,LTD.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 08800061323597
• NIH Device Record Key: ddfbcc48-2099-4830-a46e-ba08dcdb78e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccelFix Spinal Fixation System
• Version Model Number: 8101-85115S
• Company DUNS: 631159324
• Company Name: L&K BIOMED CO. ,LTD.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800061323597 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182544

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-19
• Device Publish Date: 2019-11-11

On-Brand Devices [AccelFix Spinal Fixation System]

• 08800061302448: Reduction Mono Axial Screw Ø6.5 , 115mm
• 08800061302431: Reduction Mono Axial Screw Ø6.5 , 110mm
• 08800061302424: Reduction Mono Axial Screw Ø6.5 , 105mm
• 08800061302417: Reduction Mono Axial Screw Ø6.5 , 100mm
• 08800061302400: Reduction Mono Axial Screw Ø6.5 , 95mm
• 08800061302394: Reduction Mono Axial Screw Ø6.5 , 90mm
• 08800061302387: Reduction Mono Axial Screw Ø6.5 , 85mm
• 08800061302370: Reduction Mono Axial Screw Ø6.5 , 80mm
• 08800061302363: Reduction Mono Axial Screw Ø6.5 , 75mm
• 08800061302356: Reduction Mono Axial Screw Ø6.5 , 70mm
• 08800061302349: Reduction Mono Axial Screw Ø6.5 , 65mm
• 08800061302332: Reduction Mono Axial Screw Ø6.5 , 60mm
• 08800061302325: Reduction Mono Axial Screw Ø6.5 , 55mm
• 08800061302318: Reduction Mono Axial Screw Ø6.5 , 50mm
• 08800061302301: Reduction Mono Axial Screw Ø6.5 , 45mm
• 08800061302295: Reduction Mono Axial Screw Ø6.5 , 40mm
• 08800061302288: Reduction Mono Axial Screw Ø6.5 , 35mm
• 08800061302271: Reduction Mono Axial Screw Ø6.5 , 30mm
• 08800061302264: Reduction Mono Axial Screw Ø6.5 , 25mm
• 08800061302950: Reduction Mono Axial Screw Ø7.5 , 100mm
• 08800061302943: Reduction Mono Axial Screw Ø7.5 , 95mm
• 08800061302936: Reduction Mono Axial Screw Ø7.5 , 90mm
• 08800061302929: Reduction Mono Axial Screw Ø7.5 , 85mm
• 08800061302912: Reduction Mono Axial Screw Ø7.5 , 80mm
• 08800061302905: Reduction Mono Axial Screw Ø7.5 , 75mm
• 08800061302899: Reduction Mono Axial Screw Ø7.5 , 70mm
• 08800061302882: Reduction Mono Axial Screw Ø7.5 , 65mm
• 08800061302875: Reduction Mono Axial Screw Ø7.5 , 60mm
• 08800061302868: Reduction Mono Axial Screw Ø7.5 , 55mm
• 08800061302851: Reduction Mono Axial Screw Ø7.5 , 50mm
• 08800061302844: Reduction Mono Axial Screw Ø7.5 , 45mm
• 08800061302837: Reduction Mono Axial Screw Ø7.5 , 40mm
• 08800061302820: Reduction Mono Axial Screw Ø7.5 , 35mm
• 08800061302813: Reduction Mono Axial Screw Ø7.5 , 30mm
• 08800061302806: Reduction Mono Axial Screw Ø7.5 , 25mm
• 08800061302790: Reduction Mono Axial Screw Ø7.5 , 20mm
• 08800061302783: Reduction Mono Axial Screw Ø7.0 , 150mm
• 08800061302776: Reduction Mono Axial Screw Ø7.0 , 145mm
• 08800061302769: Reduction Mono Axial Screw Ø7.0 , 140mm
• 08800061302752: Reduction Mono Axial Screw Ø7.0 , 135mm
• 08800061302745: Reduction Mono Axial Screw Ø7.0 , 130mm
• 08800061302738: Reduction Mono Axial Screw Ø7.0 , 125mm
• 08800061302721: Reduction Mono Axial Screw Ø7.0 , 120mm
• 08800061302714: Reduction Mono Axial Screw Ø7.0 , 115mm
• 08800061302707: Reduction Mono Axial Screw Ø7.0 , 110mm
• 08800061302691: Reduction Mono Axial Screw Ø7.0 , 105mm
• 08800061302684: Reduction Mono Axial Screw Ø7.0 , 100mm
• 08800061302677: Reduction Mono Axial Screw Ø7.0 , 95mm
• 08800061302660: Reduction Mono Axial Screw Ø7.0 , 90mm
• 08800061302653: Reduction Mono Axial Screw Ø7.0 , 85mm