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Found 6 results
510(k) Data Aggregation
K Number
K140644Device Name
PROCEM
Manufacturer
OTOTRONIX, LLC
Date Cleared
2014-06-19
(98 days)
Product Code
NEA
Regulation Number
872.3275Why did this record match?
Product Code :
NEA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ProCem™ is intended for non-weight bearing applications in Otologic surgery, such as:
1. Reconstruction of ossicular bones or mechanical coupling of the ossicular chain.
2. Mechanical stabilization of middle ear and cochlear implants.
3. Attachment of middle ear implants to the ossicular bones.
Device Description
ProCem™ is glass ionomer cement that is provided as two components, a glass powder and polyacrylic acid liquid. By mixing the two components, viscous moldable ionomeric cement is obtained which hardens in situ. ProCem™ is provided in a sterile capsule. The capsule includes the two separate components, a glass powder and polyacrylic acid liquid. An activator is used to release the liquid component prior to use. The capsule is then placed in a mixer, which mixes the glass powder and polyacrylic acid liquid to form a compliant cement. The applicator is used to apply the compliant cement to the appropriate location in the middle ear. The cement then hardens in place to provide a permanent bond.
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K Number
K080032Device Name
ENVOYCEM, MODEL 1640
Manufacturer
ENVOY MEDICAL CORPORATION
Date Cleared
2008-02-28
(52 days)
Product Code
NEA
Regulation Number
872.3275Why did this record match?
Product Code :
NEA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EnvoyCem is intended for use in otologic surgery for the following applications:
- Augmentation or coupling of the middle ear ossicles.
- Attachment of the middle ear ossicles to middle ear implants.
- Mechanical stabilization of middle ear prostheses.
Device Description
EnvoyCem is glass ionomer cement that is provided as two components, a glass powder and polyalkenoic acid liquid. By mixing the two components, viscous moldable ionomeric cement is obtained which hardens in situ.
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K Number
K060750Device Name
STRYKER INJECTABLE CEMENT
Manufacturer
STRYKER CMF
Date Cleared
2006-04-19
(29 days)
Product Code
NEA
Regulation Number
872.3275Why did this record match?
Product Code :
NEA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Stryker® Injectable Cement is indicated for use in the following: augmentation or coupling of the middle ear ossicles, attachment of the middle ear ossicles to middle ear implants, mechanical stabilization of middle ear prostheses, and the reconstruction of the posterior canal wall.
Device Description
Hydroxyapatite Cement. Powder and liquid mixed to form a paste for application. Injectable Cement. Calcium Phosphate material. Sterile.
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K Number
K042516Device Name
OTOMIMIX
Manufacturer
WALTER LORENZ SURGICAL, INC.
Date Cleared
2004-11-08
(53 days)
Product Code
NEA
Regulation Number
872.3275Why did this record match?
Product Code :
NEA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OtoMimix™ is indicated for the following:
1. Augmentation or coupling of the middle ear ossicles.
2. Attachment of the middle ear ossicles to middle ear implants.
3. Mechanical stabilization of middle ear prostheses
4. Reconstruction of the posterior canal wall
Device Description
OtoMimix™ is a sterile calcium phosphate Bone Replacement product. When mixed with a stering solution, it becomes moldable material for use in otology procedures. With time, this moldable filler material hardens.
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K Number
K011338Device Name
OTO-CEM
Manufacturer
OTOTECH, INC.
Date Cleared
2001-09-13
(134 days)
Product Code
NEA
Regulation Number
872.3275Why did this record match?
Product Code :
NEA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003567Device Name
SERENOCEM, MODEL BC 010
Manufacturer
CORINTHIAN MEDICAL LTD.
Date Cleared
2001-02-12
(84 days)
Product Code
NEA
Regulation Number
872.3275Why did this record match?
Product Code :
NEA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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