SQUALE 380013

GUDID 03607503800136

Anterior Cervical Cage W20 x D15 x H05, 4°

IMPLANET

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: 03607503800136
• NIH Device Record Key: bcbd5dc2-d4c9-49e4-9959-a2205554b3a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SQUALE
• Version Model Number: 380013
• Catalog Number: 380013
• Company DUNS: 291993439
• Company Name: IMPLANET
• 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: false
• Expiration Date: true
• 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	03607503800136 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230026

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

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: 2023-06-14
• Device Publish Date: 2023-06-06

On-Brand Devices [SQUALE]

• 03607505800226: Trial Implant Holder
• 03607505800219: Trial implant W20 x D15 x H09, 4degree
• 03607505800202: Trial implant W20 x D15 x H08, 4degree
• 03607505800196: Trial implant W20 x D15 x H07, 4degree
• 03607505800189: Trial implant W20 x D15 x H06, 4degree
• 03607505800172: Trial implant W20 x D15 x H05, 4degree
• 03607505800165: Trial implant W20 x D15 x H04, 4degree
• 03607505800158: Trial implant W17 x D13 x H09, 4degree
• 03607505800141: Trial implant W17 x D13 x H08, 4degree
• 03607505800134: Trial implant W17 x D13 x H07, 4degree
• 03607505800127: Trial implant W17 x D13 x H06, 4degree
• 03607505800110: Trial implant W17 x D13 x H05, 4degree
• 03607505800103: Trial implant W17 x D13 x H04, 4degree
• 03607505800097: Trial implant W14 x D13 x H09, 4degree
• 03607505800080: Trial implant W14 x D13 x H08, 4degree
• 03607505800073: Trial implant W14 x D13 x H07, 4degree
• 03607505800066: Trial implant W14 x D13 x H06, 4degree
• 03607505800059: Trial implant W14 x D13 x H05, 4degree
• 03607505800042: Trial implant W14 x D13 x H04, 4degree
• 03607505800035: Instrumentation Box – cover
• 03607505800028: Instrumentation Box – base
• 03607505800011: Pusher
• 03607505800004: Impactor
• 03607503800174: Anterior Cervical Cage W20 x D15 x H09, 4°
• 03607503800167: Anterior Cervical Cage W20 x D15 x H08, 4°
• 03607503800150: Anterior Cervical Cage W20 x D15 x H07, 4°
• 03607503800143: Anterior Cervical Cage W20 x D15 x H06, 4°
• 03607503800136: Anterior Cervical Cage W20 x D15 x H05, 4°
• 03607503800129: Anterior Cervical Cage W20 x D15 x H04, 4°
• 03607503800112: Anterior Cervical Cage W17 x D13 x H09, 4°
• 03607503800105: Anterior Cervical Cage W17 x D13 x H08, 4°
• 03607503800099: Anterior Cervical Cage W17 x D13 x H07, 4°
• 03607503800082: Anterior Cervical Cage W17 x D13 x H06, 4°
• 03607503800075: Anterior Cervical Cage W17 x D13 x H05, 4°
• 03607503800068: Anterior Cervical Cage W17 x D13 x H04, 4°
• 03607503800051: Anterior Cervical Cage W14 x D13 x H09, 4°
• 03607503800044: Anterior Cervical Cage W14 x D13 x H08, 4°
• 03607503800037: Anterior Cervical Cage W14 x D13 x H07, 4°
• 03607503800020: Anterior Cervical Cage W14 x D13 x H06, 4°
• 03607503800013: Anterior Cervical Cage W14 x D13 x H05, 4°
• 03607503800006: Anterior Cervical Cage W14 x D13 x H04, 4°