FDA.reportPublic FDA data

Patient-Specific TMJ Condylar Prosthesis (RIGHT SIDE)

Primary DI
M9575001100
Brand
Patient-Specific TMJ Condylar Prosthesis (RIGHT SIDE)
Company
Nexus Cmf, L.L.C.
Model
500110
Device description
Patient-Specific TMJ Condylar Prosthesis (RIGHT SIDE)
Published
2014-10-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
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
M9575001100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Mandibular condyle prosthesisA sterile implantable device designed to replace the natural mandibular condylar head, providing an articulation with the mandibular fossa and a partial substitution of the temporomandibular joint articulation. It is typically made of a combination of a metal frame and plastic (e.g., polymethylmethacrylate) or a combination of metal and polymeric materials. The device is almost always used in combination with mandibular fossa components in total temporomandibular joint (TMJ) prostheses.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
965540227
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M957500092055mm Stock TMJ Condylar Prosthesis (LEFT SIDE and RIGHT SIDE)5000922014-11-11
M9575001090Patient-Specific TMJ Condylar Prosthesis (LEFT SIDE)5001092014-10-15
M957500090045mm Stock TMJ Condylar Prosthesis (LEFT SIDE and RIGHT SIDE)5000902014-11-11
M957500091050mm Stock TMJ Condylar Prosthesis (LEFT SIDE and RIGHT SIDE)5000912014-11-11
M95750042302.7 x 10.0 mm screws [7]5004232014-11-11
M95750009502.0 × 10.0 mm Screw5000952014-11-11
M95750009902.7 × 8.0 mm Screw5000992014-11-11
M95750010002.7 × 10.0 mm Screw5001002014-11-11
M95750010102.7 × 12.0 mm Auxiliary Screw5001012014-11-11
M95750010203.0 × 8.0 mm Auxiliary Screw5001022014-11-11
M95750010303.0 × 10.0 mm Auxiliary Screw5001032014-11-11
M95750010403.0 × 12.0 mm Auxiliary Screw5001042014-11-11
M95750011202.7x8.0mm [2] & 2.7x10.0mm [5] Screws5001122016-09-02
M95750042002.0 x 6.0 mm screws [5]5004202014-11-11
M95750042102.0 x 8.0 mm screws [5]5004212014-11-11
M95750009302.0 × 6.0 mm Screw5000932014-11-11
M95750009402.0 × 8.0 mm Screw5000942014-11-11
M95750009702.3 × 8.0 mm Auxiliary Screw5000972014-11-11
M95750009802.3 × 10.0 mm Auxiliary Screw5000982014-11-11
M95750011102.0x6.0mm [1] & 2.0x8.0mm [4] Screws5001112016-09-02

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