FDA.reportPublic FDA data

Stock TMJ Fossa-Eminence Prosthesis (LEFT 05)

Primary DI
M9575000050
Brand
Stock TMJ Fossa-Eminence Prosthesis (LEFT 05)
Company
Nexus Cmf, L.L.C.
Model
500005
Device description
Stock TMJ Fossa-Eminence Prosthesis (LEFT 05)
Published
2014-11-06
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
MPIGlenoid Fossa Prosthesis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZDJoint, Temporomandibular, ImplantDental3
MPIGlenoid Fossa ProsthesisDental3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M9575000050PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Mandibular fossa prosthesisA sterile implantable component of a total temporomandibular joint (TMJ) prosthesis designed to replace or repair the articulating surface of the joint comprised of the glenoid fossa and the articulating eminence of the temporal bone. It is cup-like in shape and typically made of polyethylene (PE); it may include screws for attachment to temporal bone.

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
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

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