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510(k) Data Aggregation
K Number
K040134Device Name
THERILINK BONE VOID FILLER
Manufacturer
Date Cleared
2004-03-09
(48 days)
Product Code
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
THERICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
TheriLink™ Bone Void Filler is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The product is intended for use in defects of the skeletal system (i.e. the extremities, spine and pelvis). TheriLink™ parts create a network within the defect site that resorbs during healing and is replaced by bone.
Device Description
The TheriLink™ Bone Void Filler is constructed of synthetic ß-tricalcium phosphate (ß-TCP), a commonly found mineral in bone. The porosity and geometric features of ß-tricalcium phosphate create a network within the defect site that resorbs during healing and is replaced by native bone.
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K Number
K031040Device Name
THERIFIL BONE FILLER
Manufacturer
Date Cleared
2003-07-24
(114 days)
Product Code
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
THERICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
TheriFil™ Bone Void Filler is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The product is intended for use in defects of the skeletal system (i.e. the extremities, spine and pelvis). TheriFil™ parts create an interlocking network within the defect site that resorbs during healing and is replaced by bone.
Device Description
The TheriFil™ Bone Void Filler is constructed of synthetic ß-tricalcium phosphate, a commonly found mineral in bone. The porosity and geometric features of B-tricalcium phosphate create an interlocking network within the defect site that resorbs during healing and is replaced by native bone.
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K Number
K023998Device Name
THERIRIDGE BLOCK, BONE GRAFT SUBSTITUTE
Manufacturer
Date Cleared
2003-03-26
(113 days)
Product Code
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
THERICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
TheriRidge™ Block Bone Graft Substitute is indicated and intended for the augmentation of deficient maxillary and mandibular alveolar ridges.
Device Description
The TheriRidge™ Block device consists of hydroxylapatite material, the primary mineral content of human bone, with porosity and geometric features that encourage tissue in-growth. The device will be available in three (3) basic sizes: small (approximately 10.4 mm x 5.6 x 5.0), medium (approximately 10.4 mm x 10.0 x 5.0), and large (approximately 20.0 mm x 10.0 x 5.0).
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