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510(k) Data Aggregation
K Number
K102577Device Name
FORCE MEDICAL IM NAIL SYSTEM
Manufacturer
Date Cleared
2012-05-03
(603 days)
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
FORCE MEDICAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Force Medical IM Nail is intended for tibiotalocalcaneal (TTC) arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot.
Indications for use include:
- Posttraumatic and primary Arthrosis
- Neuromuscular deformity
- Revision of Failed Ankle Arthrodesis
- Failed Total Ankle Replacement
- Avascular Necrosis of the Talus (requiring tibiocalcaneal arthrodesis)
- A Neuroarthropathy (Charcot)
- Rheumatoid Arthritis with severe deformity
- Osteoarthritis
- Pseudarthrosis
Device Description
The Force Medical IM Nail System is an angled (left & right) and straight (left & right due to hole orientation), cannulated, intramedullary nail in multiple diameters(8) and in multiple lengths(3) manufactured from High Strength 6-4 Titanium Alloy to ASTM F136. The nail features proximal, distal, and midshaft angled hole(s) to receive Alloyed Titanium transverse locking 4.5mm Cortical and 4.5/6.5 Transition Cortical - Cancellous Bone Screws (in various lengths). Endcaps (in 0+ and 6 lengths in 4 diameters) in the Titanium Alloy are available for nail end bottom screw locking and IM Nail length extension. A Titanium Alloy Compression Washer and Screw (in 5 lengths) is also available for joint compression(s) if distal talocalcaneal fusion is required. All alloyed titanium components have a Type II anodize surface treatment and are anodize color coded for left/right versions. A full set of guide/placement instrumentation is available for accurate placement and alignment of the bone screws within the nail when used in conjuction with x-ray fluoroscopy.
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K Number
K081603Device Name
DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300
Manufacturer
Date Cleared
2009-07-24
(413 days)
Regulation Number
870.2320Why did this record match?
Applicant Name (Manufacturer) :
HEARTFORCE MEDICAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The dBG 300 records vibrational waveforms produced by the hearts contractions and transmitted to the chest wall. The dBG 300 may be used as a tool to measure the timing of the events in the cardiac cycle.
Device Description
The Heart Force Ballistocardiograph senses and analyzes the mechanical movement of the heart. This is accomplished with 2 or 3 standard ECG electrodes for the ECG signal and with a suitable miniature electronic accelerometer for the mechanical motion.
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