ADVANCE® - ADVANCE® II POST STAB TIBIAL INSERT SIZE 6 17mm - Microport Orthopedics Inc.

Duns Number:079118736

Device Description: ADVANCE® II POST STAB TIBIAL INSERT SIZE 6 17mm

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More Product Details

Catalog Number

KIPS2617

Brand Name

ADVANCE®

Version/Model Number

KIPS2617

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Conditional

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

-

Product Code Details

Product Code

HRY

Product Code Name

Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

Device Record Status

Public Device Record Key

a6aa431d-a2b5-4339-91ad-f751bf74e946

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 20, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MICROPORT ORTHOPEDICS INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7823
2 A medical device with a moderate to high risk that requires special controls. 12222
3 A medical device with high risk that requires premarket approval 109