Catalog Number

TN-LL-5285

Brand Name

LapiLock

Version/Model Number

TN-LL-5285

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 12, 2022

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

-

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

c4c7803f-5c8a-4264-b76e-b02f6a97c2de

Public Version Date

October 13, 2022

Public Version Number

2

DI Record Publish Date

January 17, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-