FDA.reportPublic FDA data

55mm Stock TMJ Condylar Prosthesis (LEFT SIDE and RIGHT SIDE)

Primary DI
M9575000920
Brand
55mm Stock TMJ Condylar Prosthesis (LEFT SIDE and RIGHT SIDE)
Company
Nexus Cmf, L.L.C.
Model
500092
Device description
55mm Stock TMJ Condylar Prosthesis (LEFT SIDE and RIGHT SIDE)
Published
2014-11-11
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
M9575000920PrimaryHIBCC0

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
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
M9575001100Patient-Specific TMJ Condylar Prosthesis (RIGHT SIDE)5001102014-10-15
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