Catalog Number

TN-LL-6502

Brand Name

LapiLock

Version/Model Number

TN-LL-6502

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 25, 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

a2ff65c0-d649-43e5-8966-6ef9ec756bc3

Public Version Date

October 13, 2022

Public Version Number

2

DI Record Publish Date

July 16, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-