Vusion CS Plus - 12 mm x 5 mm x 7 Degree Lordotic - Ortho Development Corporation

Duns Number:876542390

Device Description: 12 mm x 5 mm x 7 Degree Lordotic

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More Product Details

Catalog Number

-

Brand Name

Vusion CS Plus

Version/Model Number

159-1205-07A

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

K122588

Product Code Details

Product Code

ODP

Product Code Name

Intervertebral fusion device with bone graft, cervical

Device Record Status

Public Device Record Key

9f8ff39f-2021-48ac-b64f-6df541dfdb82

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 15, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORTHO DEVELOPMENT CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3694
2 A medical device with a moderate to high risk that requires special controls. 3650