Catalog Number

-

Brand Name

SImmetry LAG Implant, 12.5mm x 95mm

Version/Model Number

10-PL12595-01

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

K151818

Product Code

OUR

Product Code Name

Sacroiliac Joint Fixation

Public Device Record Key

43751480-a9a0-4291-869b-19b85cd2fa79

Public Version Date

June 10, 2021

Public Version Number

2

DI Record Publish Date

January 25, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-