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Location profile
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486 West 350 North

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 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, 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 specification.
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, manufacture, assembly of non-sterile instrumentation and the manufacture of sterile Osteotomes and Femoral Trephines, Endoscopic and Laparoscopic devices, plastic and metal surgical delivery systems, injected molded products, 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 MDR 731770 Standard/scheme number or name (EU) 2017/745 Annex IX Chapter I and III Start date 2021-08-06 Expiry date 2026-08-05
Scope
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