FDA.reportPublic FDA data

Patient-Fitted TMJ Reconstructive Prosthesis System

Primary DI
07613327626896
Brand
Patient-Fitted TMJ Reconstructive Prosthesis System
Company
TMJ Solutions, Inc.
Model
61-2306
Device description
2.3 x 6 mm Self-Tapping Bone Screw
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
P980052000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P980052000TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESISStryker Leibinger, GmbH & Co KG1999-07-02LZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B0046123060PreviousHIBCC0
07613327626896PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327626896076133276268967613327626896

GMDN Terms#

Term, Definition table
TermDefinition
Total temporomandibular joint prosthesisA sterile artificial substitute for the temporomandibular joint (TMJ) implanted to treat patients with osteoarthritis, rheumatoid arthritis, congenital malformations, or neoplasms of the joint, as well as after trauma (e.g., fracture). It consists of mandibular condyle and mandibular fossa components implanted to functionally reconstruct the TMJ in the jaw. It is typically made of metal and/or polymeric materials. Fixation devices for implantation (e.g., screws) may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
Sterilization required before use
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
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
07613327627763Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11