Catalog Number

-

Brand Name

Lateral Suture Anchor, PEEK 4.5mm x 20mm

Version/Model Number

L-4520

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

-

Product Code

MBI

Product Code Name

Fastener, Fixation, Nondegradable, Soft Tissue

Public Device Record Key

c87fa9f9-fbee-4e04-a53b-50f1b77f56e6

Public Version Date

May 06, 2020

Public Version Number

4

DI Record Publish Date

December 31, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-