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Found 5 results
510(k) Data Aggregation
K Number
K192371Device Name
BioZorb SP Marker
Manufacturer
Focal Therapeutics
Date Cleared
2019-09-26
(27 days)
Product Code
NEU
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
Focal Therapeutics
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BioZorb SP Marker is indicated for radiographic marking of sites in soft tissue. In addition, the Marker is indicated in situations where the soft tissue site needs to be marked for future medical procedures.
Device Description
The BioZorb SP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb SP Marker is comprised of a bioabsorbable PLA (polylactic acid) component which resorbs completely in 1 year or more and a permanent component (titanium). The BioZorb SP Marker is provided sterile for single use and is implantable.
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K Number
K171467Device Name
BioZorb Marker GOLD / LP Marker GOLD
Manufacturer
Focal Therapeutics
Date Cleared
2017-11-09
(175 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
Focal Therapeutics
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Marker is intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization.
Device Description
The BioZorb Marker GOLD / LP Marker GOLD is an implantable radiopaque marker comprised of a bioabsorbable component and a permanent component. The BioZorb Marker GOLD / LP Marker GOLD is provided sterile for single use and is implantable.
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K Number
K152070Device Name
BioZorb LP Marker
Manufacturer
FOCAL THERAPEUTICS
Date Cleared
2015-08-26
(30 days)
Product Code
NEU
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
FOCAL THERAPEUTICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BioZorb LP Marker is indicated for radiographic marking of sites in soft tissue. In addition, the Marker is indicated in situations where the soft tissue site needs to be marked for future medical procedures.
Device Description
The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb LP Marker is comprised of a bioabsorbable PLA (polylactic acid) component which resorbs completely in 1 year or more and a permanent component (titanium). The BioZorb LP Marker is provided sterile for single use and is implantable.
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K Number
K143484Device Name
BioZorb Marker
Manufacturer
FOCAL THERAPEUTICS
Date Cleared
2015-06-29
(203 days)
Product Code
NEU
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
FOCAL THERAPEUTICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BioZorb Marker is indicated for radiographic marking of sites in soft tissue. In addition, the Marker is indicated in situations where the soft tissue site needs to be marked for future medical procedures.
Device Description
The BioZorb Marker is an implantable radiopaque marker comprised of a bioabsorbable PLA (polylactic acid) component which resorbs completely in 1 or more years and a permanent component (titanium). The BioZorb Marker is provided sterile for single use and is implantable.
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K Number
K113202Device Name
TISSUE MARKER
Manufacturer
FOCAL THERAPEUTICS
Date Cleared
2012-02-28
(120 days)
Product Code
NEU
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
FOCAL THERAPEUTICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BioZorb™ Tissue Marker is indicated for radiographic marking of sites in soft tissue.
Device Description
The BioZorb Tissue Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb Tissue Marker is comprised of a bioabsorbable component and a permanent component. The BioZorb Tissue Marker is provided sterile for single use and is disposable.
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