Mustang Knotless Suture Anchor - Mustang Knotless Suture Anchor, 4.75mm - RESPONSIVE ORTHOPEDICS LLC

Duns Number:002745858

Device Description: Mustang Knotless Suture Anchor, 4.75mm

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More Product Details

Catalog Number

915000-4750

Brand Name

Mustang Knotless Suture Anchor

Version/Model Number

915000-4750

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

K222763

Product Code Details

Product Code

MBI

Product Code Name

Fastener, Fixation, Nondegradable, Soft Tissue

Device Record Status

Public Device Record Key

156ebdd2-d324-4999-a68d-20ec57f2f0c3

Public Version Date

October 26, 2022

Public Version Number

1

DI Record Publish Date

October 18, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RESPONSIVE ORTHOPEDICS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 106
2 A medical device with a moderate to high risk that requires special controls. 69