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3724 North State Road 15

Warsaw

46582

USA

Certificate/license number Standard/scheme number or name Start date Expiry date
Certificate/license number MDSAP 689249 Standard/scheme number or name MDSAP Start date 2019-04-15 Expiry date 2025-04-07
Scope
The design, development, manufacturer, assembly, distribution and service of non-sterile instrumentation and the manufacture of sterile Osteotomes and Femoral Trephines, Endoscopic and Laparoscopic devices, electrosurgical graspers, plastic and metal surgical delivery systems, injected molded products, additive manufacturing, coupled with non- sterile and pre- sterile packaging of medical devices. The mentioned services encompass, but are not limited to providing sub- contract resource services for the following industries: Orthopedic, Spine, Endoscopy, Laparoscopy, Trauma and Dental. Contract manufacture of Orthopedic, Arthroscopic, Spinal Fixation, precision forged instrumentation and implants, along with surface finishing and precision machining to customer specifications.
Certificate/license number Standard/scheme number or name Start date Expiry date
Certificate/license number FM 704485 Standard/scheme number or name ISO 13485:2016 Start date 1996-06-27 Expiry date 2025-04-07
Scope
The design, development, manufacturer, assembly, distribution and service of non-sterile instrumentation and the manufacture of sterile Osteotomes and Femoral Trephines, Endoscopic and Laparoscopic devices, electrosurgical graspers, plastic and metal surgical delivery systems, injected molded products, additive manufacturing, coupled with non- sterile and pre- sterile packaging of medical devices. The mentioned services encompass, but are not limited to providing sub- contract resource services for the following industries: Orthopedic, Spine, Endoscopy, Laparoscopy, Trauma and Dental. Contract manufacture of Orthopedic, Arthroscopic, Spinal Fixation, precision forged instrumentation and implants, along with surface finishing and precision machining to customer specifications.

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