ORTHOLOC® - ORTHOLOC® II POST STAB TIBIAL INSERT THICK MD/MD+ - Microport Orthopedics Inc.

Duns Number:079118736

Device Description: ORTHOLOC® II POST STAB TIBIAL INSERT THICK MD/MD+ 30mm

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More Product Details

Catalog Number

18500164

Brand Name

ORTHOLOC®

Version/Model Number

18500164

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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

-

Product Code Details

Product Code

JWH

Product Code Name

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

Device Record Status

Public Device Record Key

2a4e1684-5fae-4e34-bc76-26e23fd161a1

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