InQu IQSP-GR-130

GUDID M896IQSPGR1300

lnQu is a resorbable bone void filler intended to fill bony gaps or voids that are not intrinsic to the stability of the bony structure.InQu is intended for use as a bone graft substitute in the skeletal system (extremities and pelvis). lnQu is indicated for use as a bone graft extender in the spine when combined with bone autograft. These defects may be surgically created or result from traumatic injury to the bone.

ARTERIOCYTE MEDICAL SYSTEMS, INC.

Synthetic bone graft

• Primary Device ID: M896IQSPGR1300
• NIH Device Record Key: 51fa3543-dfad-497e-8efe-6de17b8441c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InQu
• Version Model Number: Granules
• Catalog Number: IQSP-GR-130
• Company DUNS: 809012870
• Company Name: ARTERIOCYTE MEDICAL SYSTEMS, INC.
• 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
HIBCC	M896IQSPGR1300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071428

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

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: 2022-07-01
• Device Publish Date: 2022-06-23

On-Brand Devices [InQu]

• M896IQSPMX1250: lnQu is a resorbable bone void filler intended to fill bony gaps or voids that are not intrinsic
• M896IQSPGR1300: lnQu is a resorbable bone void filler intended to fill bony gaps or voids that are not intrinsic