PERIMETER® Interbody Fusion Device - SPACER X0910103 PER TI MD 12D 26X16 - MEDTRONIC SOFAMOR DANEK, INC.

Duns Number:830350380

Device Description: SPACER X0910103 PER TI MD 12D 26X16

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More Product Details

Catalog Number

-

Brand Name

PERIMETER® Interbody Fusion Device

Version/Model Number

X0910103

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

K111525

Product Code Details

Product Code

MAX

Product Code Name

Intervertebral fusion device with bone graft, lumbar

Device Record Status

Public Device Record Key

c978519a-4ffa-45d7-82d5-c1463f9832c6

Public Version Date

February 24, 2020

Public Version Number

4

DI Record Publish Date

June 29, 2015

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