FDA.reportPublic FDA data

Patient-Fitted TMJ Reconstructive Prosthesis System

Primary DI
07613327626872
Brand
Patient-Fitted TMJ Reconstructive Prosthesis System
Company
TMJ Solutions, Inc.
Model
65-2316
Device description
2.3 x 16 mm Self-Tapping Bone Screw, 5 Pack
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
B0046523161PreviousHIBCC0
07613327626872PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327626872076133276268727613327626872

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
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
B004TYYNNNNM0Patient-Fitted TMJ Reconstructive Prosthesis SystemTYY-NNNNM2017-01-27
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

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
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
07613327627763Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11