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510(k) Data Aggregation
K Number
K111069Device Name
OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT
Manufacturer
OSTEOSYMBIONICS, LLC
Date Cleared
2011-09-22
(157 days)
Product Code
MNF
Regulation Number
878.3550Why did this record match?
Product Code :
MNF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OsteoSymbionics ST Temporalis Implant is indicated to correct temporal hollowing in patients who have had surgery involving the pterional / lateral approach to the cranium, including pterional / lateral craniotomy or decompressive craniectomy. The OsteoSymbionics ST Temporalis Implant augments the space normally occupied by the temporalis muscle. The implant is used for the reconstruction of temporal contour deformities; the reconstruction of temporal defects, and / or the augmentation / reconstruction of the space normally occupied by the temporalis muscle / temporal area (s).
Device Description
The OsteoSymbionics Temporal Implants are pre-formed implantable prosthetic implants intended to fill soft-tissue defects in a patient's cranial/craniofacial temporal region. The implants are composed of longterm implantable-grade solid silicone elastomer. The implants are available in left and right, and come in two different sizes, small and medium. The devices are provided sterile, and are attached to native tissue with commercially available suture materials.
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K Number
K002586Device Name
MEDPOR PTERIONAL SURGICAL IMPLANT
Manufacturer
POREX SURGICAL PRODUCTS GROUP
Date Cleared
2000-11-17
(88 days)
Product Code
MNF
Regulation Number
878.3550Why did this record match?
Product Code :
MNF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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