CD HORIZON® Fenestrated Screw Set - FNS SAS 55751027575 STER CCM 7.5 X 75 - MEDTRONIC SOFAMOR DANEK, INC.

Duns Number:830350380

Device Description: FNS SAS 55751027575 STER CCM 7.5 X 75

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More Product Details

Catalog Number

-

Brand Name

CD HORIZON® Fenestrated Screw Set

Version/Model Number

55751027575

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

K201362

Product Code Details

Product Code

NDN

Product Code Name

CEMENT, BONE, VERTEBROPLASTY

Device Record Status

Public Device Record Key

fea63765-3379-4381-a5f8-9ace6d0d83d3

Public Version Date

October 27, 2020

Public Version Number

1

DI Record Publish Date

October 19, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTRONIC SOFAMOR DANEK, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 13352
2 A medical device with a moderate to high risk that requires special controls. 26085
3 A medical device with high risk that requires premarket approval 190
U Unclassified 75