Catalog Number

-

Brand Name

Tendon Anchor System 1 Hole 10mm

Version/Model Number

20070

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

K132510

Product Code

HTN

Product Code Name

Washer, Bolt Nut

Public Device Record Key

c9d1c1b9-d9c9-4816-830b-4903d00a82a7

Public Version Date

March 21, 2019

Public Version Number

5

DI Record Publish Date

September 16, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-