Duns Number:324331826
Device Description: Device Name: Matriform SI-StripIndication for Use:Matriform® Si Strip is intended to fill Device Name: Matriform SI-StripIndication for Use:Matriform® Si Strip is intended to fill bony voids or gaps of the skeletal system (posterolateral spine). These osseous defects may be surgically created or from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. In the posterolateral spine Matriform® Si Strip is to be mixed with autograft bone. The device resorbs and is replaced with bone during the healing process
Catalog Number
1 x 5 cc
Brand Name
Matriform SI-Strip
Version/Model Number
50x25x4 mm
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
K160566
Product Code
MQV
Product Code Name
Filler, Bone Void, Calcium Compound
Public Device Record Key
65b510ef-8a67-4898-bc38-722ab4537474
Public Version Date
February 28, 2020
Public Version Number
1
DI Record Publish Date
February 20, 2020
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 58 |