Catalog Number

-

Brand Name

Stock TMJ Fossa-Eminence Prosthesis (LEFT 01)

Version/Model Number

500001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 31, 2017

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

LZD

Product Code Name

Joint, Temporomandibular, Implant

Public Device Record Key

86c1a7ee-e5e3-4014-9b50-f5d836a0477b

Public Version Date

November 25, 2020

Public Version Number

5

DI Record Publish Date

November 06, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-