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510(k) Data Aggregation
K Number
K133082Device Name
OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE
Manufacturer
OSTEOSYMBIONICS, LLC
Date Cleared
2014-05-20
(232 days)
Product Code
GXN
Regulation Number
882.5330Why did this record match?
Applicant Name (Manufacturer) :
OSTEOSYMBIONICS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OsteoSymbionics Patient-Specific Cranial Implants are designed individually for each patient to correct cranial defects.
Device Description
The OsteoSymbionics Patient Specific Cranial Implants are individually sized and shaped implantable prosthetic cranioplasty plates intended to fill cranial defects in a specific patient. The implants are composed of polymethyl methacrylate and are fabricated using the patient's CT imaging data. The devices are provided sterile and are attached to the native bone with commercially available cranioplasty fasteners.
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K Number
K121102Device Name
OSTEOSYMBIONICS PEEK CRANIAL IMPLANT
Manufacturer
OSTEOSYMBIONICS, LLC
Date Cleared
2012-08-08
(119 days)
Product Code
GXN
Regulation Number
882.5330Why did this record match?
Applicant Name (Manufacturer) :
OSTEOSYMBIONICS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OsteoSymbionics PK Shield (PEEK Patient Specific Cranial Implant) is designed individually for each patient to correct defects in cranial bone.
Device Description
OsteoSymbionics Patient-Specific Cranial Implant (PEEK), manufactured by OsteoSymbionics, LLC, is a prosthetic cranioplasty implant. Each implant is sized and shaped from one or more pieces to fit the specific patient's cranial skeleton. The devices are manufactured from PEEK and provided non-sterile for sterilization prior to implantation. Implantable prosthetic cranioplasty implants are intended to fill a specific patient's defect, so each device is manufactured one at a time to custom-order based upon the patient's CT scan. The device can be crafted to include perfusion holes (2mm in diameter, spaced 10mm apart) upon surgeon preference (on order sheet). The implants are attached to the native bone with commercially available cranioplasty fasteners.
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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?
Applicant Name (Manufacturer) :
OSTEOSYMBIONICS, LLC
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
K072601Device Name
OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT
Manufacturer
OSTEOSYMBIONICS, LLC
Date Cleared
2007-12-10
(87 days)
Product Code
GXP, GXN
Regulation Number
882.5300Why did this record match?
Applicant Name (Manufacturer) :
OSTEOSYMBIONICS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OsteoSymbionics Patient Specific Cranial Implants are designed individually for each patient to correct defects in craniofacial bone.
Device Description
The OsteoSymbionics Patient Specific Cranial Implants are individually sized and shaped implantable prosthetic cranioplasty plates intended to fill defects in a specific patient's cranial/craniofacial skeleton. The implants are composed of polymethyl methacrylate and are fabricated using the patient's CT imaging data. The devices are provided non-sterile for sterilization prior to implantation and are attached to the native bone with commercially available cranioplasty fasteners.
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