Catalog Number

-

Brand Name

Syntec-Taichung Non-sterile Bone Plate and Screw Implants

Version/Model Number

245100

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

K983495

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Public Device Record Key

9def933b-afbc-4ebd-9d25-a9b4b5e83790

Public Version Date

July 29, 2019

Public Version Number

1

DI Record Publish Date

July 19, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-