PERIMETER® C Spinal System - SPACR X1214541 PER C TI STER 6D 7X15X13 - MEDTRONIC SOFAMOR DANEK, INC.

Duns Number:830350380

Device Description: SPACR X1214541 PER C TI STER 6D 7X15X13

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More Product Details

Catalog Number

-

Brand Name

PERIMETER® C Spinal System

Version/Model Number

X1214541

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

K153438

Product Code Details

Product Code

ODP

Product Code Name

Intervertebral fusion device with bone graft, cervical

Device Record Status

Public Device Record Key

30aac26a-752b-45b6-9422-012362946e54

Public Version Date

February 24, 2020

Public Version Number

4

DI Record Publish Date

February 05, 2018

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