KAINOS+ - KAINOS+ is a microporous and macroporous biphasic - SIGNUS Medizintechnik GmbH

Duns Number:344203948

Device Description: KAINOS+ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of KAINOS+ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% Hydroxyapatite (HA) and 40% beta-Tricalcium Phosphate (ß-TCP). KAINOS+ is available in various shapes and sizes. KAINOS+ may be used with physiolo-gical saline, patient’s own serum, whole blood, or bone marrow aspirate (BMA).

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More Product Details

Catalog Number

K002NT

Brand Name

KAINOS+

Version/Model Number

Bone graft substitute, granulate 2-3mm

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K090387

Product Code Details

Product Code

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Device Record Status

Public Device Record Key

272166b3-4cf8-47e4-b366-9301216a8213

Public Version Date

June 19, 2020

Public Version Number

7

DI Record Publish Date

September 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIGNUS MEDIZINTECHNIK GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 522
2 A medical device with a moderate to high risk that requires special controls. 1837