Duns Number:809012870
Device Description: lnQu is a resorbable bone void filler intended to fill bony gaps or voids that are not int 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.
Catalog Number
IQSP-MX-125
Brand Name
InQu
Version/Model Number
Matrix
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K071428
Product Code
MQV
Product Code Name
Filler, Bone Void, Calcium Compound
Public Device Record Key
0f82391a-2c78-4c5d-a13c-734f6ae2e22c
Public Version Date
July 01, 2022
Public Version Number
1
DI Record Publish Date
June 23, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |