Catalog Number

SPEG1.8-14

Brand Name

Torx Smooth Peg

Version/Model Number

SPEG1.8-14

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

K951302

Product Code

JDS

Product Code Name

NAIL, FIXATION, BONE

Public Device Record Key

9409d398-4906-446e-b40e-b250eb762f6e

Public Version Date

May 15, 2019

Public Version Number

1

DI Record Publish Date

May 07, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-