SQUALE 380002

GUDID 03607503800020

Anterior Cervical Cage W14 x D13 x H06, 4°

IMPLANET

Polymeric spinal interbody fusion cage

• Primary Device ID: 03607503800020
• NIH Device Record Key: 11e36520-4f8f-4a41-9405-7f84e4dd2ca2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SQUALE
• Version Model Number: 380002
• Catalog Number: 380002
• 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	03607503800020 [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°