Affix - Affix® III Plate, 45mm - Nuvasive, Inc.

Duns Number:053950783

Device Description: Affix® III Plate, 45mm

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More Product Details

Catalog Number

-

Brand Name

Affix

Version/Model Number

1719045

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

-

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

K133052

Product Code Details

Product Code

PEK

Product Code Name

Spinous process plate

Device Record Status

Public Device Record Key

800c30b5-fe36-4bf4-8f61-5ba957fef343

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NUVASIVE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4207
2 A medical device with a moderate to high risk that requires special controls. 38751
3 A medical device with high risk that requires premarket approval 84
U Unclassified 29