FDA.reportPublic FDA data

TMJ SYSTEM

Primary DI
00841036036508
Brand
TMJ SYSTEM
Company
BIOMET MICROFIXATION, INC
Model
24-6556
Catalog number
24-6556
Device description
55 MM LEFT STANDARD MANDIBULAR COMPONENT
Published
2014-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
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
P020016006
P020016007

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P020016006WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEMBiomet Microfixation, Inc.2005-09-21LZD
P020016007WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEMBiomet Microfixation, Inc.2005-09-21LZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841036036508PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036036508008410360365088410360365080841036036508

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

Contacts#

Phone, Email table
PhoneEmail
904-741-4400FXJAX-ORDERS@BIOMET.COM

Regulatory Flags#

DUNS number
046189866
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841036019112N/A02-008302-00832017-06-05
00888233028875Pectus Blu (TM)78-880178-88012026-07-23
00888233028882Pectus Blu (TM)78-880278-88022026-07-23
00888233028899Pectus Blu (TM)78-880378-88032026-07-23
00888233086110Pectus Blu (TM)78-005378-00532026-07-23
00888233086127Pectus Blu (TM)78-005578-00552026-07-23
00888233086134Pectus Blu (TM)78-720078-72002026-07-23
00888233086141Pectus Blu (TM)78-725078-72502026-07-23
00888233086158Pectus Blu (TM)78-730078-73002026-07-23
00888233086165Pectus Blu (TM)78-735078-73502026-07-23
00888233086172Pectus Blu (TM)78-740078-74002026-07-23
00888233086189Pectus Blu (TM)78-745078-74502026-07-23
00888233086196Pectus Blu (TM)78-750078-75002026-07-23
00888233086202Pectus Blu (TM)78-755078-75502026-07-23
00888233086219Pectus Blu (TM)78-800178-80012026-07-23
00888233085021PECTUS BLU (TM)78-820078-82002026-01-27
00888233085038PECTUS BLU (TM)78-825078-82502026-01-27
00810128536875PECTUS BLU (TM)78-850078-85002024-09-30
00888233077170PECTUS BLU (TM)78-800078-80002024-09-30
00888233077187PECTUS BLU (TM)78-808078-80802024-09-30

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