Mecta-C Ti mark - Cervical Interbody Fusion Device TiPEEK “Dome - Medacta International SA

Duns Number:488227125

Device Description: Cervical Interbody Fusion Device TiPEEK “Dome shaped” 15x18x9 L5°- Ti markers

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More Product Details

Catalog Number

-

Brand Name

Mecta-C Ti mark

Version/Model Number

03.28.330

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

K172587

Product Code Details

Product Code

ODP

Product Code Name

Intervertebral Fusion Device With Bone Graft, Cervical

Device Record Status

Public Device Record Key

3ec02490-c21c-4aa9-b737-acdcc24c49f0

Public Version Date

November 02, 2021

Public Version Number

1

DI Record Publish Date

October 25, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDACTA INTERNATIONAL SA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8200
2 A medical device with a moderate to high risk that requires special controls. 9084