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Mizuho OSI Axis Jackson System

Solicitation Number: N6264509RCES076
Agency: Department of the Navy
Office: Bureau of Medicine and Surgery
Location: NMLC
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N6264509RCES076
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Presolicitation
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Added: Feb 19, 2009 1:43 pm
The Naval Medical Logistics Command intends to negotiate on a sole source basis (IAW FAR 13.5) with Mizuho Orthopedic Systems Inc, 30031 Ahern Ave, Union City, CA 94587, as the only responsible source that is capable of providing a Mizuho OSI Axis Jackson operating table System.



Specifically, the requirement is for an operating table. The operating table system shall include a power hinged frame, controller with cable set, adjustable arm boards, control pad system, hip/thigh pads, bilateral winged chest pad, two-piece carbon fiber supine tops, two inch pad with translation slide, supine top 6 inch side rail adaptor, removable foot board, adjustable leg sling, retractor adaptor, buttocks strap, safety straps, positioning pillows, pivoting arm board, cross arm support, lateral arm board, Clarke socket, aluminum side rail socket, and deluxe lateral positioner. This system shall also come with an advanced control retractable base. This table shall have a weight limit of 500 pounds, allow C-arm integration, stimulate pressure points during surgery, and allow for 360 degree rotation. The rotational capability shall facilitate 360 degree spinal fusions without the need to move the patient for repositioning. This element shall allow horizontal axis rotation in prone or supine positions and shall allow unique, multiplanar, intraoperative images of spine and pelvis.



The table top shall measure 84 inches in length by 17 inches in width. The frame and support pads shall be completely radiolucent. The table shall be able to support the following procedures: laminectomies, decompressions, osteotomies, anterior/posterior fusions, surgical correction of deformities, anterior/posterior cervicals, kyphoplasties, and idet surgeries.



The Mizuho OSI Axis Jackson System is the only system compatible with the replacement spinal table and an existing installed base of tables. In addition, Mizuho Orthopedic Systems Inc is the only manufacturer that can supply a table with 360 degree spinal fusion capability without the need to reposition the patient.



The system shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States.



This acquisition is being conducted under simplified acquisition procedures (IAW FAR 13.5). There are no set-aside restrictions for this requirement. The intended procurement will be classified under North American Industry Classification System (NAICS) 339112 with a Small Business Size Standard of 500 employees. This notice of intent is not a request for competitive proposals and no solicitation document exists for this requirement. However, parties interested in responding to this notice will need to submit technical data sufficient to determine capability in providing the same product. Due to the urgency of this requirement, all capability statements received within 15 days after publication of this synopsis will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.



Capability statements shall be submitted by email only as a MS Word or Adobe PDF attachment to James Suerdieck at james.suerdieck@med.navy.mil. Statements are due by COB 05 MAR 2009. No phone calls accepted.
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1681 Nelson St
FT Detrick, Maryland 21702-9203
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693 Neiman Street
Fort Detrick, Maryland 21702
United States
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James D. Suerdieck,
Contract Specialist
Phone: 301-619-3060
Fax: 301-619-2925
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Burzie C Baker III,
Contracting Officer
Phone: 301-619-0707
Fax: 301-619-2925