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Found 5 results
510(k) Data Aggregation
K Number
K002633Device Name
SILMAX PECTORAL IMPLANT
Manufacturer
PILLAR SURGICAL, INC.
Date Cleared
2000-11-21
(90 days)
Product Code
MIC
Regulation Number
874.3620Why did this record match?
Applicant Name (Manufacturer) :
PILLAR SURGICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002629Device Name
SILMAX CONTOUR CARVING BLOCK IMPLANT
Manufacturer
PILLAR SURGICAL, INC.
Date Cleared
2000-11-20
(89 days)
Product Code
JOF
Regulation Number
874.3620Why did this record match?
Applicant Name (Manufacturer) :
PILLAR SURGICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K992239Device Name
PILLAR CHIN IMPLANT
Manufacturer
PILLAR SURGICAL, INC.
Date Cleared
1999-11-22
(143 days)
Product Code
FWP
Regulation Number
878.3550Why did this record match?
Applicant Name (Manufacturer) :
PILLAR SURGICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Each Pillar Chin Implant is indicated for the augmentation or reconstruction of facial chin deformities, congenital or acquired by trauma or disease.
Device Description
The Pillar Chin Implant is made from identical liquid elastomer materials and manufacturing processes as the predicate device. The raw materials are Nusil's MED 4211 unrestricted silicone fluid from Nusil Technologies, Inc. The durometers or hardness (shore A) of each implant will range from 5 to 30. The appearance is described as clear to opaque. Tensile strength averages 700 psi and the percent of elongation is over 400 percent.
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K Number
K992240Device Name
PILLAR MALAR IMPLANT
Manufacturer
PILLAR SURGICAL, INC.
Date Cleared
1999-11-22
(143 days)
Product Code
LZK
Regulation Number
878.3550Why did this record match?
Applicant Name (Manufacturer) :
PILLAR SURGICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Each Pillar Malar Implant is indicated for the augmentation or reconstruction of malar eminence deficiencies, whether congenital or acquired by trauma or disease.
Device Description
The Pillar Malar Implant is made from identical liquid elastomer materials and manufacturing processes as the predicate device. The physical properties of this device are the same as the predicate device in that equivalent materials will be used in manufacturing. The raw materials are Nusil's MED 4211 unrestricted silicone fluid from Nusil Technologies, Inc. The durometers or hardness (shore A) of each implant will range from 5 to 30. The appearance is described as clear to opaque. Tensile strength averages 700 psi and the percent of elongation is over 400 percent.
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K Number
K992242Device Name
PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS
Manufacturer
PILLAR SURGICAL, INC.
Date Cleared
1999-11-22
(143 days)
Product Code
FZE
Regulation Number
878.3680Why did this record match?
Applicant Name (Manufacturer) :
PILLAR SURGICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Each Pillar Nasal Implant is indicated for the augmentation or reconstruction of nasal eminence deficiencies, whether congenital or acquired by trauma or disease.
Device Description
The Pillar Nasal Implant is made from identical liquid elastomer materials and manufacturing processes as the predicate device. The raw materials are Nusil's MED 4211 unrestricted silicone fluid from Nusil Technologies, Inc. The durometers or hardness (shore A) of each implant will range from 5 to 30. The appearance is described as clear to opaque. Tensile strength averages 700 psi and the percent of elongation is over 400 percent.
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