Search Results
Found 7 results
510(k) Data Aggregation
K Number
K133285Device Name
STRYKER TEMPORARY CONDYLAR PROSTHESIS
Manufacturer
Stryker
Date Cleared
2014-04-09
(166 days)
Product Code
NEI
Regulation Number
872.4770Why did this record match?
Product Code :
NEI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Stryker Temporary Condylar Prostheses are intended for temporary (not exceeding 24 months) reconstruction in patients undergoing ablative tumor surgery requiring removal of the mandibular condyle.
Device Description
The Stryker Temporary Condylar Prosthesis is an independent solid condylar head which is rigidly connected to a standard or locking Stryker Reconstruction plate via fastening screws. The Temporary Condylar Prosthesis is provided in a left and right configuration and is intended for temporary use only (not exceeding 24 months). The Condylar Prosthesis is made of commercially pure titanium and the head of the condyles is PVD (Physical Vapor Deposition) coated which differentiates it from the rest of the condyles giving it golden color. The Temporary Condylar Prosthesis is accompanied by connecting screws which are made of commercially pure titanium alloy and are specifically designed to fixate the Prosthesis with a Stryker plate.
Ask a Question
K Number
K081747Device Name
MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM
Manufacturer
SYNTHES (USA)
Date Cleared
2008-09-05
(78 days)
Product Code
NEI
Regulation Number
872.4770Why did this record match?
Product Code :
NEI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).
Device Description
The Synthes Condylar Head Add-on System is an adjustable height add-on system for use with the 2.4 mm Locking Reconstruction Plate System and MatrixMANDIBLE Plate System. It consists of a condylar head, 2 screws, and one of four (4) fixation plates, each with a different screw hole spacing that determines the height of the condylar head.
Ask a Question
K Number
K063181Device Name
SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM
Manufacturer
SYNTHES (USA)
Date Cleared
2007-01-05
(78 days)
Product Code
NEI
Regulation Number
872.4770Why did this record match?
Product Code :
NEI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).
Device Description
The Synthes (USA) Condylar Head Add-on System is an adjustable height system intended for use with Synthes' 2.4 mm Locking Reconstruction Plate (LRP) System. The system consists of an elliptical shaped condylar head, four different fixation plates which allow the surgeon to adjust the height of the condylar head, and two fixation screws for mounting the condylar head and fixation plate onto a 2.4 mm locking reconstruction plate.
Ask a Question
K Number
K031701Device Name
OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM
Manufacturer
OSTEOMED L.P.
Date Cleared
2004-07-08
(402 days)
Product Code
NEI
Regulation Number
872.4770Why did this record match?
Product Code :
NEI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indicated for temporary reconstruction of the mandibular condyle in patients who have undergone resective procedures to remove malignant or benign tumors requiring the removal of the mandibular condyle. This device is not intended for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD). Implants are intended for single patient use.
Device Description
The OsteoMed Temporary Condylar Attachment system is a solid condylar head which attaches with fastening screws to an OsteoMed Fracture Reconstruction Plate. The OsteoMed Temporary Condylar Attachment is available for right and left placement. System instruments include drivers.
Ask a Question
K Number
K002790Device Name
ADD-ON CONDYLE
Manufacturer
WALTER LORENZ SURGICAL, INC.
Date Cleared
2001-08-06
(333 days)
Product Code
NEI
Regulation Number
872.4770Why did this record match?
Product Code :
NEI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K990667Device Name
KLS-MARTIN TEMPORARY CONDYLAR IMPLANT
Manufacturer
KLS-MARTIN L.P.
Date Cleared
2001-07-27
(878 days)
Product Code
NEI
Regulation Number
872.4770Why did this record match?
Product Code :
NEI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KLS-Martin Temporary Condylar Implant is only intended for temporary reconstruction of the mandibular condyle in patients who have undergone resective procedures to remove malignant or benign tumors requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).
Device Description
The KLS-Martin Temporary Condylar Implant is a solid condylar head which attaches with fastening screws to a KLS-Martin Fracture/Reconstruction Plate. The KLS-Martin Temporary Condylar Implant is available for left and right placement.
Ask a Question
K Number
K990637Device Name
SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD
Manufacturer
SYNTHES (USA)
Date Cleared
1999-10-22
(238 days)
Product Code
NEI
Regulation Number
872.4770Why did this record match?
Product Code :
NEI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Synthes (USA) Locking Reconstruction Plate with Condylar Head is intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).
Device Description
The Locking Reconstruction Plate with Condylar Head is a one piece reconstruction plate with a solid condylar head. The plate features compression screw holes that are internally threaded to accept the 2.4 - 3.0 mm locking screws or standard 2.4 mm self-tapping cortex screws and has notched sides and undersides to facilitate contouring. The plates are available in three sizes for right and left placement.
Ask a Question
Page 1 of 1