Catalog Number

4727008

Brand Name

AXS, SmartLock

Version/Model Number

4727008

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K183172,K183172

Product Code

HRS

Product Code Name

Plate, fixation, bone

Public Device Record Key

d20dddad-f2b2-47f5-81da-02120ce05cc3

Public Version Date

May 22, 2019

Public Version Number

1

DI Record Publish Date

May 14, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-