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510(k) Data Aggregation
K Number
K002324Device Name
MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA
Manufacturer
SULZER MEDICA
Date Cleared
2000-08-24
(24 days)
Product Code
JDI, KRO, LZO
Regulation Number
888.3350Why did this record match?
Applicant Name (Manufacturer) :
SULZER MEDICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K993667Device Name
SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS
Manufacturer
SULZER MEDICA
Date Cleared
2000-01-28
(88 days)
Product Code
DSY
Regulation Number
870.3450Why did this record match?
Applicant Name (Manufacturer) :
SULZER MEDICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sulzer Vascutek SEALPTFE™ grafts are intended for the creation of subcutaneous arteriovenous conduits for blood access, bypass, or reconstruction of occluded or diseased arterial blood vessels. Typical applications for standard wall grafts include systemic vascular repair, primarily for axillo-femoral/bifemoral bypass and femoral-popliteal reconstruction. Typical applications for thin wall grafts include systemic vascular repair, but not for axillo-femoral/bifemoral bypass reconstruction.
Device Description
The Sulzer Vascutek SEALPTFE™ gelatin-sealed expanded polytetrafluoroethylene (PTFE) graft line is composed of PTFE, which has been fabricated in tubular form and expanded to impart porosity to the structure. The PTFE material has been impregnated with an absorbable mammalian gelatin that is intended to reduce intraoperative suture hole bleeding. The gelatin is of USP standard and is derived from bovine bone sourced exclusively in the United States. The gelatin used in the impregnation process is a non-antigenic and non-toxic protein. It has been crosslinked to control its dissolution rate. The gelatin hydrolyzes within approximately 14 days. The gelatin is identical to that used with Sulzer Vascutek's gelatin-sealed knitted and woven polyester grafts and knitted cardiovascular fabric.
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K Number
K993569Device Name
APR METASUL ACETABULAR INSERT
Manufacturer
SULZER MEDICA
Date Cleared
1999-12-01
(41 days)
Product Code
KWA
Regulation Number
888.3330Why did this record match?
Applicant Name (Manufacturer) :
SULZER MEDICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The APR Metasul Acetabular Inserts are intended for use with the APR Acetabular Shells and Metasul femoral heads in total hip arthroplasty for treatment of the following:
- patient conditions of noninflammatory degenerative joint disease (NIDJD); e.g., avascular ● necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- those patients with failed previous surgery where pain, deformity, or dysfunction persists. .
- revision of a previously failed arthroplasty. .
Device Description
The APR Metasul Acetabular Insert is a modular metal insert which is hemispherical in shape and has an outer diameter manufactured from polyethylene (UHMWPE, ASTM F648). The outer diameter of the insert is machined with locking features that mate with one of the previously cleared APR metallic acetabular shells.
The inner diameter which forms the bearing surface of this insert features a metallic Metasul inlay that is integrally locked to the polyethylene portion. The metal inlay is manufactured from Protasul"-21WF, a wrought forged CoCrMo alloy (ISO 5832-4, ISO 5832-12). This inlay is polished to a mirror-finish and hot-pressed into the UHMWPE backing. Just prior to hot-pressing, two Protasul-10 (CoCr alloy, ASTM F562) pins may be press fit into the design of the inlay to help provide added rotational stability. As a result of the strictly controlled tolerances of the inlay and in order to recognize the beneficial wear properties associated with this component, this insert is designed for use only with previously cleared head components.
The APR Metasul Acetabular Insert component is available with outside diameters of 49mm to 81mm (in 2mm increments) with an inner diameter of 28mm.
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K Number
K992832Device Name
SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS
Manufacturer
SULZER MEDICA
Date Cleared
1999-11-19
(88 days)
Product Code
DSY
Regulation Number
870.3450Why did this record match?
Applicant Name (Manufacturer) :
SULZER MEDICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sulzer Vascutek ePTFE grafts are intended for the creation of subcutaneous arteriovenous conduits for blood access, bypass, or reconstruction of occluded or diseased arterial blood vessels.
Device Description
The device is composed of polytetrafluoroethylene, which has been fabricated in tubular form and expanded to impart porosity to the structure.
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