TLC Uni Knee Meniscal Insert - SIGNATURE ORTHOPAEDICS PTY LTD

Duns Number:751993028

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More Product Details

Catalog Number

-

Brand Name

TLC Uni Knee Meniscal Insert

Version/Model Number

121-21-2101

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K212870

Product Code Details

Product Code

HSX

Product Code Name

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

Device Record Status

Public Device Record Key

97b23990-2932-4147-b6b8-2c073c600b0b

Public Version Date

July 08, 2022

Public Version Number

1

DI Record Publish Date

June 30, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIGNATURE ORTHOPAEDICS PTY LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1701
2 A medical device with a moderate to high risk that requires special controls. 3746