CE - FDA Certified
Our products are approved by the FDA and CE.
Stating the high quality of our products.
Patented Products
The ULC cap and many of our designs are patented. So you can offer unique products to your customers.
Easy to Install
We make the life of medical doctors easier. This ULC cap is really easy to instal. Surgeons will never go back to older screws after using ours.
Safer Products
The locking system with our ULC Cap is safer for patients because it reduces drastically the loosening due to stress and movements of the patient.
ULC Cap - Unitary Locking Cap
Unique and patented cap. Safer than the regular nuts.
ULC spinal pedicle screw system was developed to help surgeons achieve more efficient spine surgeries. Our proprietary Unitary Locking Cap(ULC) is designed to achieve a super tight screw-rod fixture that provides permanent stable grip and to reduce operating time.
TCB - Transverse Connection Bar
Used to correct, decompress, and fix parts affected by diseases such as deformity of the spine (thoracic vertebrae, lumbar vertebra, cervical vertebral), spinal canal stenosis, and fracture
The Transverse Connection Bar secures stability against the torsion in the spine axis under treatment with pedicle screws. In case pedicle screws are used for the overall spine or local part concentratively, the bar secures the fixing force transversely to stabilize the movement of the rod connected to pedicle screws.
Cervical Occipital System
Made of High-End Titanium.
The system is composed of Cervical Screws, Occipital Bone Screws, Occipital Plate (Plus and Arrow Type), and Rod Connectors.
Reduced Profile
ULC pedicle screw’s superior mechanical properties ensure enhanced performance. The reduced profile (12mm) was chosen for patient’s maximum comfort post operation.
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.
1
2
3
4
1
ULC Special Cap
2
Low Profile
3
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
1
2
1
Low Profile OTIS Screws
2
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 |