Matriform SI-Strip - Device Name: Matriform StripIndication for - curasan AG

Duns Number:324331826

Device Description: Device Name: Matriform StripIndication for Use:Matriform® Si Strip is intended to fill bon Device Name: Matriform 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

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More Product Details

Catalog Number

1 x 10 cc

Brand Name

Matriform SI-Strip

Version/Model Number

100x25x4mm

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Device Record Status

Public Device Record Key

1eb511f8-51f4-41c6-b5b3-7253eddc6838

Public Version Date

February 28, 2020

Public Version Number

1

DI Record Publish Date

February 20, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CURASAN AG" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 58