HEDRON - HEDRON IC Spacer, 10x16, 8mm, 0° - GLOBUS MEDICAL, INC.

Duns Number:139105691

Device Description: HEDRON IC Spacer, 10x16, 8mm, 0°

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More Product Details

Catalog Number

-

Brand Name

HEDRON

Version/Model Number

1213.6008S

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

K191243

Product Code Details

Product Code

ODP

Product Code Name

Intervertebral fusion device with bone graft, cervical

Device Record Status

Public Device Record Key

dc80cdd1-0841-4827-a26e-9fc8158c3880

Public Version Date

February 24, 2020

Public Version Number

2

DI Record Publish Date

November 13, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GLOBUS MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4975
2 A medical device with a moderate to high risk that requires special controls. 34645
3 A medical device with high risk that requires premarket approval 57
U Unclassified 232