Search Results
Found 14 results
510(k) Data Aggregation
K Number
K992522Device Name
SPECTRUM DESIGNS SPECTRAGEL
Manufacturer
SPECTRUM DESIGNS, INC.
Date Cleared
1999-10-26
(90 days)
Product Code
MDA, CLA
Regulation Number
878.4025Why did this record match?
Applicant Name (Manufacturer) :
SPECTRUM DESIGNS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Spectrum Designs Spectragel is indicated for use in the topical mangement of hypertrophic and keloid scars. Spectrum Designs Spectragel may also be used prophylactically to help retard the formation of such scars.
Device Description
Spectragel is used only on intact skin and is manufactured out of medical grade, biocompatible silicone material.
Ask a Question
K Number
K982688Device Name
SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK
Manufacturer
SPECTRUM DESIGNS, INC.
Date Cleared
1998-10-13
(71 days)
Product Code
MIB
Regulation Number
874.3620Why did this record match?
Applicant Name (Manufacturer) :
SPECTRUM DESIGNS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spectrum Designs Pre-Form Contour Silicone Carving Block is a pre-formed solid silicone block, to be used where a shaped, cut-to-fit implant is desired. It is designed for use in augmenting or reconstructing cartilaginous tissue, soft tissue and bone. The preshaped aspect of the implant allows the surgeon increased options when cutting or shaping the implant to the size and shape demanded by a specific surgical situation.
Device Description
The Spectrum Designs Pre-Form Contour Silicone Carving Block Implant is fabricated from solid silicone elastomer and has an inherent, pre-formed, rounded shape.
Ask a Question
K Number
K980444Device Name
SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT
Manufacturer
SPECTRUM DESIGNS, INC.
Date Cleared
1998-05-06
(90 days)
Product Code
FWP
Regulation Number
878.3550Why did this record match?
Applicant Name (Manufacturer) :
SPECTRUM DESIGNS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spectrum Designs Bilateral Groove Chin Implant is intended to augment or reconstruct congenital or traumatic chin deficiencies.
Device Description
The Spectrum Designs Bilateral Chin Implant is manufactured from medical grade solid silicone elastomer which is implanted in a pocket created by the surgeon, either intraorally or extraorally, in the mandibular region of the facial skeleton. It is provided non-sterile and available in six sizes.
Ask a Question
K Number
K980445Device Name
SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT
Manufacturer
SPECTRUM DESIGNS, INC.
Date Cleared
1998-05-06
(90 days)
Product Code
FWP
Regulation Number
878.3550Why did this record match?
Applicant Name (Manufacturer) :
SPECTRUM DESIGNS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spectrum Designs Concave Back Chin Implant is intended to augment or reconstruct congenital or traumatic chin deficiencies.
Device Description
The Spectrum Designs Concave Back Chin Implant is manufactured from medical grade solid silicone elastomer which is implanted in a pocket created by the surgeon, either intraorally or extraorally, in the mandibular region of the facial skeleton. It is provided non-sterile and available in six sizes.
Ask a Question
K Number
K980446Device Name
SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT
Manufacturer
SPECTRUM DESIGNS, INC.
Date Cleared
1998-05-06
(90 days)
Product Code
FWP
Regulation Number
878.3550Why did this record match?
Applicant Name (Manufacturer) :
SPECTRUM DESIGNS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spectrum Designs Anterior Chin Implant is intended to augment or reconstruct congenital or traumatic chin deficiencies.
Device Description
The Spectrum Designs Anterior Chin Implant is manufactured from medical grade solid silicone elastomer which is implanted in a pocket created by the surgeon, either intraorally or extraorally, in the mandibular region of the facial skeleton. It is provided non-sterile and available in six sizes.
Ask a Question
K Number
K980462Device Name
SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT
Manufacturer
SPECTRUM DESIGNS, INC.
Date Cleared
1998-05-06
(90 days)
Product Code
FWP
Regulation Number
878.3550Why did this record match?
Applicant Name (Manufacturer) :
SPECTRUM DESIGNS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spectrum Designs Anatomical Chin Implant is intended to augment or reconstruct congenital or traumatic chin deficiencies.
Device Description
The Spectrum Designs Anatomical Chin Implant is manufactured from medical grade solid silicone elastomer which is implanted in a pocket created by the surgeon, either intraorally or extraorally, in the mandibular region of the facial skeleton. It is provided non-sterile and available in two sizes.
Ask a Question
K Number
K980463Device Name
SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT
Manufacturer
SPECTRUM DESIGNS, INC.
Date Cleared
1998-05-06
(90 days)
Product Code
FWP
Regulation Number
878.3550Why did this record match?
Applicant Name (Manufacturer) :
SPECTRUM DESIGNS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spectrum Designs Curvilinear Chin Implant is a silicone facial implant, designed to augment or reconstruct the mandibular or chin area of the face.
Device Description
The Spectrum Designs Curvilinear Chin Implant is manufactured from medical grade solid silicone elastomer. It is provided non-sterile and available in three sizes.
Ask a Question
K Number
K980138Device Name
SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT
Manufacturer
SPECTRUM DESIGNS, INC.
Date Cleared
1998-04-03
(78 days)
Product Code
FWP
Regulation Number
878.3550Why did this record match?
Applicant Name (Manufacturer) :
SPECTRUM DESIGNS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spectrum Designs Symmetrical Chin Implant is intended to augment or reconstruct the mandibular or chin area of the face.
Device Description
Spectrum Designs Symmetrical Chin Implant is manufactured from solid silicone elastomer which is implanted in a pocket created by the surgeon, either intraorally or extraorally, in the mandibular region of the facial skeleton.
Ask a Question
K Number
K980461Device Name
SPECTRUM DESIGNS CLEFT CHIN IMPLANT
Manufacturer
SPECTRUM DESIGNS, INC.
Date Cleared
1998-03-04
(27 days)
Product Code
FWP, EWP
Regulation Number
878.3550Why did this record match?
Applicant Name (Manufacturer) :
SPECTRUM DESIGNS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spectrum Designs Cleft Chin Implant is intended to augment or reconstruct the mandibular or chin area of the face.
Device Description
The Spectrum Designs Cleft Chin Implant is manufactured from solid silicone elastomer which is implanted in a pocket created by the surgeon, either intraorally or extraorally, in the mandibular region of the facial skeleton.
Ask a Question
K Number
K980139Device Name
SPECTRUM DESIGNS PROFILE MALAR IMPLANT
Manufacturer
SPECTRUM DESIGNS, INC.
Date Cleared
1998-03-03
(47 days)
Product Code
LZK
Regulation Number
878.3550Why did this record match?
Applicant Name (Manufacturer) :
SPECTRUM DESIGNS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spectrum Designs Profile Malar Implant is intended to augment or reconstruct the malar region of the face.
Device Description
Spectrum Designs Profile Malar Implant is manufactured from solid silicone elastomer. The implant is implanted in a pocket created by the surgeon in the malar-zygomatic region of the facial skeleton to augment the existing facial structure.
Ask a Question
Page 1 of 2