FDA.reportPublic FDA data

Patient-Fitted TMJ Reconstructive Prosthesis System

Primary DI
B004TYYNNNNM0
Brand
Patient-Fitted TMJ Reconstructive Prosthesis System
Company
TMJ Solutions, Inc.
Model
TYY-NNNNM
Device description
Anatomical Bone Model
Published
2017-01-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LZDJoint, Temporomandibular, Implant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZDJoint, Temporomandibular, ImplantDental3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B004TYYNNNNM0PrimaryHIBCC0

Regulatory Flags#

DUNS number
035877922
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327627763Patient-Fitted TMJ Reconstructive Prosthesis SystemCHG024AM2023-09-11
07613327627770Patient-Fitted TMJ Reconstructive Prosthesis SystemCHG026AM2023-09-11
07613327627787Patient-Fitted TMJ Reconstructive Prosthesis SystemCHG020AM2023-09-11
07613327627800Patient-Fitted TMJ Reconstructive Prosthesis SystemCHG010AM2023-09-11
B004YYMMDDNNNNLF0Patient-Fitted TMJ Reconstructive Prosthesis SystemYYMMDDNNNNLF2021-11-10
B004YYMMDDNNNNLM0Patient-Fitted TMJ Reconstructive Prosthesis SystemYYMMDDNNNNLM2021-11-10
B004YYMMDDNNNNM0Patient-Fitted TMJ Reconstructive Prosthesis SystemYYMMDDNNNNM2021-11-10
B004YYMMDDNNNNRF0Patient-Fitted TMJ Reconstructive Prosthesis SystemYYMMDDNNNNRF2021-11-10
B004YYMMDDNNNNRM0Patient-Fitted TMJ Reconstructive Prosthesis SystemYYMMDDNNNNRM2021-11-10
B004TYYNNNNLF0Patient-Fitted TMJ Reconstructive Prosthesis SystemTYY-NNNNLF2017-01-27
B004TYYNNNNLM0Patient-Fitted TMJ Reconstructive Prosthesis SystemTYY-NNNNLM2017-01-27
B004TYYNNNNRF0Patient-Fitted TMJ Reconstructive Prosthesis SystemTYY-NNNNRF2017-01-27
B004TYYNNNNRM0Patient-Fitted TMJ Reconstructive Prosthesis SystemTYY-NNNNRM2017-01-27
07613327626650Patient-Fitted TMJ Reconstructive Prosthesis System61-20062023-09-11
07613327626674Patient-Fitted TMJ Reconstructive Prosthesis System61-20122023-09-11
07613327626681Patient-Fitted TMJ Reconstructive Prosthesis System65-20052023-09-11
07613327626698Patient-Fitted TMJ Reconstructive Prosthesis System61-20082023-09-11
07613327626704Patient-Fitted TMJ Reconstructive Prosthesis System61-20162023-09-11
07613327626711Patient-Fitted TMJ Reconstructive Prosthesis System65-20062023-09-11
07613327626728Patient-Fitted TMJ Reconstructive Prosthesis System65-20082023-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327626551Patient-Fitted TMJ Reconstructive Prosthesis SystemStryker Leibinger GmbH & Co. KGLZD2023-09-11
07613327626568Patient-Fitted TMJ Reconstructive Prosthesis SystemStryker Leibinger GmbH & Co. KGLZD2023-09-11
07613327626575Patient-Fitted TMJ Reconstructive Prosthesis SystemStryker Leibinger GmbH & Co. KGLZD2023-09-11
07613327626605Patient-Fitted TMJ Reconstructive Prosthesis SystemStryker Leibinger GmbH & Co. KGLZD2023-09-11
07613327626650Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626674Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626681Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626698Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626704Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626711Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626728Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626742Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626759Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626766Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626773Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626780Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626797Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626803Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626810Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626827Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626834Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626841Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626858Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626865Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626872Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626889Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626896Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626902Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626919Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626926Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11