Catalog Number

921.102.SMA

Brand Name

Trinity Acetabular Hip System with HXLPE Liners

Version/Model Number

921.102.SMA

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

-

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

K110087

Product Code

LZO

Product Code Name

Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Public Device Record Key

3a5fc1a1-a730-41f9-b3c7-7c4b6011534e

Public Version Date

April 23, 2019

Public Version Number

6

DI Record Publish Date

August 17, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-