Catalog Number

T80316

Brand Name

GUIDED GROWTH PLATE SYSTEM

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K180624

Product Code

OBT

Product Code Name

Plate, Bone, Growth Control, Pediatric, Epiphysiodesis

Public Device Record Key

f6dc31f9-5568-45cb-b264-fdabd3b7859a

Public Version Date

June 07, 2019

Public Version Number

1

DI Record Publish Date

May 30, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-