FDA UDI
In Commercial Distribution
🇺🇸 United States
InQu
DI: M896IQSPGR1300
·
Model: Granules
·
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- InQu
- Primary DI
- M896IQSPGR1300
- Version / Model
- Granules
- Catalog Number
- IQSP-GR-130
- Company Name
- ARTERIOCYTE MEDICAL SYSTEMS, INC.
- Labeler DUNS
- 809012870
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-23
- Public Version
- 1
- Public Version Date
- 2022-07-01
- Public Version Status
- New
- Public Device Record Key
- 51fa3543-dfad-497e-8efe-6de17b8441c1
Device Description
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | Orthopedic | 888.3045 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16966 | Synthetic bone graft | An artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M896IQSPGR1300 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K071428 | 000 |