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510(k) Data Aggregation
K Number
K170449Device Name
Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protection
Manufacturer
Millennium Medical Technologies, Inc.
Date Cleared
2017-03-31
(44 days)
Product Code
MUU
Regulation Number
878.5040Why did this record match?
Applicant Name (Manufacturer) :
Millennium Medical Technologies, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Millennium Medical Technologies, Inc. Autoclavable Suction Jars and Lids are used in conjunction with hospital or surgery center vacuum and/or cleared pumps, tubing and cannulas, for the collection of aspirated fat, for aesthetic body contouring. If the fat is untreated, it may be reinjected via a cleared injection apparatus.
Device Description
The Millennium Medical Technologies line of Fat Collection and Transfer Devices consist of the following:
1. Autoclavable Suction Jars and lids with Luer Lock extension and extraction tub - 250, 500, 1,000, 2,000 and 3,000 ml
2. Suction Jar without Luer Lock extension 1,500 and 2,500 ml
3. Sterile 1,500 and 2,500 ml Lids with Conical patient connection 6-10 and overflow protection
The Millennium Medical Technologies Collection Jars are Suction Canisters molded from medical grade polycarbonate. The 250, 500, 1,000, 2,000 and 3,000 ml canisters have a stainless steel luer fitting at its base to facilitate the transfer of untreated fat back into the patient using a cleared injection apparatus. The 1,500 and 2.500 ml canisters are designed to interface with the Lid with Liner and do not have a fitting at the base of the canister. All of the Collection Jars are provided non-sterile and are autoclavable.
The Millennium Medical Technologies Small and Large Lids are molded from medical grade polypropylene and have various ports, medical grade silicone tubing and a liner to contain all waste. The Large Lid has a 6-10 tapered cone for the 2,500 ml canister and the Small Lid has a 6-10 tapered cone for the 1,500 ml canister. The Lids with Liner are provided sterile.
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K Number
K081039Device Name
LIPO CANNULA
Manufacturer
MILLENNIUM MEDICAL TECHNOLOGIES, INC.
Date Cleared
2008-07-10
(90 days)
Product Code
QPB, GEA, MUU
Regulation Number
878.5040Why did this record match?
Applicant Name (Manufacturer) :
MILLENNIUM MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Liposuction cannulas are indicated for aesthetic body countering and tissue aspiration
Device Description
Not Found
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K Number
K031050Device Name
PCW PERCUTANEOUS COMPRESSION WIRE
Manufacturer
MILLENNIUM MEDICAL TECHNOLOGIES, INC.
Date Cleared
2003-07-14
(103 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
MILLENNIUM MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Percutaneous Compression Wire system for the fixation of osseous fragments or fractures of small bones, including:
- Scaphoid fractures
- Lunate fractures
- Capitate
- Carpal fractures & non-unions
- Capitellum fractures
- Humeral head fractures
- Trapezial fractures
- Metacarpal and metatarsal fractures
- Phalangeal fractures
- Distal radial fractures
- Ulnar styloid fractures
- Osteo-chrondral fractures
- Small joint fusions
- Glenoid fractures
- Intercarpal fusions
- Interphalangeal fractures
- Metatarsal osteotomies
- Tarsal fusions
- Malleolar fractures
- Hammer toe fixation
Device Description
The PCW" is supplied as a single length threaded stainless steel wire or pin. The pin is selftapping and self-cutting and does not vary in length or diameter. The engineering drawings include diameter and length information. However, the pins are nominally six inches in length and fifty-nine thousandths diameter. The pins are intended for small bone applications (fractures and osteotomies) including distal fragments of long bones. The principal areas of use are the upper extremity and the hands and feet. The pins may be used for selected fractures elsewhere in the body so long as medically indicated and bone mass compatible. The primary use of the wires is percutaneous, that is, without the need for an external fixatior as in the case of "hammer-toes" or similar phlangeal or small bone losteotomies. The secondary use of the wires is in association with the use of an external fixation device as a means to secure and fix small fragments until healing is complete. MMT supplies instrumentation designed specifically to interface with this implant system. Their use of general manual orthopaedic instrumentation is not recommended for the insertion of this device. The screws are made from stainless steel alloy.
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K Number
K020791Device Name
HBS HEADLESS BONE SCREW
Manufacturer
MILLENNIUM MEDICAL TECHNOLOGIES, INC.
Date Cleared
2002-06-06
(87 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
MILLENNIUM MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Headless bone screw system for the fixation of osseous fragments or fractures including:
HBS - MINI: Scaphoid fractures, Lunate fractures, Capitate, Trapezial fractures, Metacarpal and metatarsal fractures, Phalangeal fractures, Radial head fractures, Ulnar styloid fractures, Osteo-chrondral, Small joint fusions
HBS - STANDARD: Scaphoid fractures, Carpal fractures & non-unions, Capitellum fractures, Metacarpal fractures, Phalangeal fractures, Distal radial fractures, Radial head fractures, Ulnar styloid fractures, Small joint fusions, Humeral head fractures, Glenoid fractures, Intercarpal fusions, Interphalangeal fractures, Metatarsal osteotomies, Tarsal fusions, Malleolar fractures, Patellar fractures, Osteo-chrondral fractures, Odontoid fractures, Mandibular fractures
Device Description
The HBS™ (Headless Bone Screw) and the mini HBS™ are supplied as two series of cannulated bone screws varying in length and diameter. Both systems are intended for small bone applications and are thus considered a single system. Indeed, both systems are intended for use primarily in the hands and feet. The systems may be used for selected fractures elsewhere in the body so long as medically indicated and bone mass compatible.
Available screws and instrumentation are available as two individually boxed sets offered in the following sizes:
MINI HBS™: 1.5mm shaft diameter, 3.2mm proximal thread diameter, 2.5mm distal thread diameter. 10mm through 30mm length in one millimeter increments.
STANDARD HBS™: 3.0mm shaft diameter, 4.7mm proximal thread diameter, 4.0mm distal thread diameter. 10mm through 30mm length in one millimeter increments.
The screws are made from titanium alloy.
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K Number
K012294Device Name
WRISTORE FIXATOR
Manufacturer
MILLENNIUM MEDICAL TECHNOLOGIES, INC.
Date Cleared
2002-03-04
(227 days)
Product Code
KTT, 87K
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
MILLENNIUM MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Wristore Fixator is intended to provide external fixation of the upper extremity. External fixation devices allow for three plane (axial, AP & medio/lateral) control over fractures and bone segments.
Device Description
The materials utilized for the construction of the external elements of the Wristore Fixator are medical grade polyetherimide resin. This material is the identical material utilized to construct the Articulating Distal Radius Fixator (K984498). The materials utilized in the instruments and pin guides are instrument grade stainless steel. The pins and K-wires used to fix the fractured bones are produced from implant grade stainless steel (316L). The Wristore Fixator utilizes legally marketed commercially available fixation pins and/or K-wires. Once the provided K-wires and pins have been properly placed, the poly-resin external frame is tightened and the fracture(s) stabilized. Typical orthopaedic instrumentation is provided to place, tighten and adjust the fixator.
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