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510(k) Data Aggregation
K Number
K083552Device Name
MAXMORESPINE TOM STICK
Manufacturer
HOOGLAND SPINE PRODUCTS GMBH
Date Cleared
2009-10-09
(312 days)
Product Code
HRX
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
HOOGLAND SPINE PRODUCTS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The maxMorespine Endoscope when used with recommended third party accessories/components, is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as arthroplasty, nucleotomy, discectomy and foraminotomy.
Device Description
The maxMorespine Endoscope is a rigid, multi-channel endoscope comprised of a working channel, rod lens optical system to transmit light and images with irrigation channel(s) and stopcocks. The body is designed of an outer and inner tube of surgical grade stainless steel. The proximal end of the endoscope; eyepiece and light post is adaptable to industry standard endoscopic camera and light systems. The endoscope will be introduced into the patient via a minimally invasive access through a working cannula with various instruments introduced through the Endoscope working channel (maxMorespine System submitted sepatately - K090132).
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K Number
K090132Device Name
MAXMORESPINE SPINAL SYSTEM
Manufacturer
HOOGLAND SPINE PRODUCTS GMBH
Date Cleared
2009-06-09
(139 days)
Product Code
HRX
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
HOOGLAND SPINE PRODUCTS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The maxMorespine System is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures such as: arthroplasty, nucleotomy, discectomy and foraminotomy.
Device Description
The maxMorespine System consists of basic cannulas, sheaths, dilators, drills, trephines, forceps, punches, mallet and quidewires which facilitate or compliment the maxMorespine Endoscope (submitted separately under K083552). The System is designed to provide the access and treatment of spinal anatomy and pathology.
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