Catalog Number

HPC-CO01-02-01

Brand Name

Bespoke

Version/Model Number

HPC-CO01-02-01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K150780,K150780

Product Code

PLW

Product Code Name

Acetabular Cup Orientation System

Public Device Record Key

7bdd3920-029b-4246-80eb-755be7c585cd

Public Version Date

November 27, 2019

Public Version Number

4

DI Record Publish Date

July 21, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-