Catalog Number

STP4.5-600

Brand Name

PRECICE® STRYDE System

Version/Model Number

STP4.5-600

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K180503

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

d27e8024-c8b4-41da-a1e3-4649e84c7d48

Public Version Date

November 23, 2018

Public Version Number

1

DI Record Publish Date

October 23, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-