Orthopaedic & Spine Development (OSD) - Stabilize the bone fusion during the - ORTHOPAEDIC & SPINE DEVELOPMENT

Duns Number:282063846

Device Description: Stabilize the bone fusion during the consolidation processus following the surgical correc Stabilize the bone fusion during the consolidation processus following the surgical correction of the spinal anomalies.

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More Product Details

Catalog Number

-

Brand Name

Orthopaedic & Spine Development (OSD)

Version/Model Number

VREV-0013

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KWQ

Product Code Name

Appliance, Fixation, Spinal Intervertebral Body

Device Record Status

Public Device Record Key

c0cdc494-38dc-4f53-a0d3-30a70e695230

Public Version Date

January 19, 2021

Public Version Number

1

DI Record Publish Date

January 11, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORTHOPAEDIC & SPINE DEVELOPMENT" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 18