Catalog Number

177-350/35

Brand Name

SP-CL Hip Stem

Version/Model Number

177-350/35

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

K161840

Product Code

LZO

Product Code Name

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

Public Device Record Key

1fe32b09-66dc-4dfd-891f-df5d5204b127

Public Version Date

October 27, 2022

Public Version Number

2

DI Record Publish Date

January 23, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-