FDA.reportPublic FDA data

Patient-Fitted TMJ Reconstructive Prosthesis System

Primary DI
07613327627763
Brand
Patient-Fitted TMJ Reconstructive Prosthesis System
Company
TMJ Solutions, Inc.
Model
CHG024AM
Device description
Anatomical Bone Model, Accessory
Published
2023-09-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZDJoint, Temporomandibular, Implant

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P980052012

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P980052012TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESISStryker Leibinger, GmbH & Co KG1999-07-02LZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327627763PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327627763076133276277637613327627763

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made organ/bone anatomy modelA model of an organ (e.g., heart, kidney, lung) or bone of a specific patient intended to be used to assist anatomical visualization and surgical treatment planning. It is created using additive (three-dimensional [3-D] printing) processes based on patient medical images. It is typically made of a synthetic polymer, marked with a unique identifier, and may be sterilized prior to use in sterile fields.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
805-650-3391lorena.lundeen@stryker.com

Regulatory Flags#

DUNS number
035877922
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327626551Patient-Fitted TMJ Reconstructive Prosthesis SystemCHG0102023-09-11
07613327626568Patient-Fitted TMJ Reconstructive Prosthesis SystemCHG0262023-09-11
07613327626575Patient-Fitted TMJ Reconstructive Prosthesis SystemCHG0202023-09-11
07613327626605Patient-Fitted TMJ Reconstructive Prosthesis SystemCHG0242023-09-11
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
07613327626742Patient-Fitted TMJ Reconstructive Prosthesis System61-20102023-09-11
07613327626759Patient-Fitted TMJ Reconstructive Prosthesis System65-20162023-09-11
07613327626766Patient-Fitted TMJ Reconstructive Prosthesis System65-20122023-09-11
07613327626773Patient-Fitted TMJ Reconstructive Prosthesis System61-20052023-09-11
07613327626780Patient-Fitted TMJ Reconstructive Prosthesis System65-20142023-09-11
07613327626797Patient-Fitted TMJ Reconstructive Prosthesis System65-20102023-09-11
07613327626803Patient-Fitted TMJ Reconstructive Prosthesis System61-23102023-09-11
07613327626810Patient-Fitted TMJ Reconstructive Prosthesis System61-23142023-09-11
07613327626827Patient-Fitted TMJ Reconstructive Prosthesis System61-23082023-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327626551Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626568Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626575Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626605Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
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