• SPINE AND CERVICAL

    Patented and Exclusive Screws – Cutting-edge technology

Lumbar and Occipital Cervical System

Special Properties

Our pedicle screws combine a series of advatages as:

1. Patented cap (ULC) with Unitary Locking System, safer and easier to install.

2. Low profile screw, for patient comfort  and

3. Special threads for increased safety.

4. Titanium Plasma Coating (TPS) is our newer screw, special for patients with Osteoporosis.

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2
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4
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ULC Special Cap

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Low Profile

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Special Threads

4

Titanium Plasma Coating

Low Profile

The Low Profile of our screws are comfortable for patients:

1. OTIS ULC Cap

2. Other Manufacturers Screws

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2
1

Low Profile OTIS Screws

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Other Brands

TEST PERFORMED FOR OUR SCREWS

WE TAKE QUALITY VERY SERIOUS

No. Regulation & Standard No. / Name
1 Council Directive 93/42/EEC as amended by 2007/47/EC concerning medical devices
2 ISO 13485:2003 Medical devices – Quality management systems – Requirements for regulatory purposes
3 ISO 14971:2007 Medical devices – Application of risk management to medical devices
4 ISO 14630:2008 Non-active surgical implants – General requirements
5 EN 980:2008 Symbols for use in the labeling of medical devices
6 EN 1041:2008 Information supplied by the manufacturer of medical devices
7 MEDDEV 2.4/1 rev.9 Classification of medical devices
8 MEDDEV 2.12/1 rev.6 Guidelines on medical device vigilance system
9 MEDDEV 2.7/1 rev.3 Clinical evaluation: Guide for manufacturers and notified bodies
10 MEDDEV 2.12/2 Clinical Evaluation – Post Market Clinical Follow-up
11 EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects – Part 1: General requirements (ISO 14155-1:2003)
12 EN ISO 10993-1:2009/AC:2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
13 EN 556-1:2001/AC:2006 Sterilization of medical devices – Requirements for medical devices to be designated ‘STERILE’ – Part 1: Requirements for terminally sterilized medical devices
14 EN ISO 17665-1:2006 Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
15 EN ISO 11737-1:2006/AC:2009 Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products
16 EN ISO 11737-2:2009 Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
17 EN ISO 11607-1:2009 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
18 ASTM F 136-08e1 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
19 ASTM F 543-07e1 Standard Specification and Test Methods for Metallic Medical Bone Screws
20 ASTM F 1717-11a Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
21 ASTM F 1798-97(2008) Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants

Get to know more about our exclusive ULC cap and plasma spray screws. Download the brochure!

Lumbar Spine Screws – Patented Cap (ULC)

Cervical Occipital System Info

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