Catalog Number

913-0712-CM1

Brand Name

Humelock II Cemented Reversible Shoulder

Version/Model Number

913-0712-CM1

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

K150488

Product Code

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Public Device Record Key

16235277-30ff-4414-82bd-8fb4d22137c0

Public Version Date

October 07, 2021

Public Version Number

2

DI Record Publish Date

July 27, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-