Catalog Number

-

Brand Name

Patient-Fitted TMJ Reconstructive Prosthesis System

Version/Model Number

YYMMDDNNNNLF

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"

Yes

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

P980052

Product Code

LZD

Product Code Name

Joint, Temporomandibular, Implant

Public Device Record Key

95634bdf-f5b9-4edf-8eac-c669c2ee4ebf

Public Version Date

November 18, 2021

Public Version Number

1

DI Record Publish Date

November 10, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-