Question 1

What types of medical devices does Razor Medical Instruments, Inc. manufacture?

Accepted Answer

Razor Medical Instruments, Inc. specializes in orthopaedic devices used in hip replacement surgeries. Their portfolio includes single-use bone-resection tools like the RAZOR Single-Use Acetabular Reamer, which prepare the acetabular cavity during surgery, as well as reusable instruments such as the RAZOR Calcar Planer Handle and Femoral Head Trial for positioning hip joint prostheses. These devices assist surgeons in achieving precise alignment and fit during hip replacement procedures.

Question 2

Where is Razor Medical Instruments, Inc. based, and what regulatory systems do their devices follow?

Accepted Answer

Razor Medical Instruments, Inc. is headquartered in the United States. Their devices are designed and manufactured in compliance with U.S. regulatory requirements. Since all their products fall under Class I classification, they are listed in the FDA’s Unique Device Identification (UDI) system, ensuring traceability and regulatory transparency for these orthopaedic instruments.

Question 3

Which regulatory registries or databases list Razor Medical Instruments, Inc.’s devices?

Accepted Answer

Razor Medical Instruments, Inc.’s devices are included in the FDA’s Unique Device Identification (UDI) system, a centralized database that tracks medical devices authorized for use in the U.S. This system helps healthcare providers, regulators, and manufacturers maintain accurate records of device identification, manufacturing information, and regulatory status.

Question 4

How are Razor Medical Instruments, Inc.’s devices classified under medical device regulations?

Accepted Answer

All of Razor Medical Instruments, Inc.’s devices are classified as Class I medical devices. This classification applies to products posing the lowest risk to patients, typically involving minimal intervention or non-invasive procedures. Class I devices are subject to general controls, such as good manufacturing practices, but do not require pre-market approval or additional pre-market notifications beyond listing in the FDA’s UDI system.

Device	Model / Reference	Registries	Class	Status
RAZOR Single-Use Acetabular Reamer	1000-0046	FDA UDI	Class I	Active
RAZOR Single-Use Acetabular Reamer	1000-0056	FDA UDI	Class I	Active
RAZOR Single-Use Acetabular Reamer	1001-0059	FDA UDI	Class I	Active
RAZOR Single-Use Acetabular Reamer	1001-0055	FDA UDI	Class I	Active
RAZOR Single-Use Acetabular Reamer	1001-0046	FDA UDI	Class I	Active
RAZOR Single-Use Acetabular Reamer	1001-0050	FDA UDI	Class I	Active
RAZOR Single-Use Acetabular Reamer	1001-0064	FDA UDI	Class I	Active
RAZOR Single-Use Acetabular Reamer	1001-0056	FDA UDI	Class I	Active
RAZOR Single-Use Acetabular Reamer	1000-0047	FDA UDI	Class I	Active
RAZOR Femoral Head Trial	1105-0036-P	FDA UDI	Class I	Active
RAZOR Calcar Planer Handle	1103-0000	FDA UDI	Class I	Active
RAZOR Single-Use Acetabular Reamer	1000-0052	FDA UDI	Class I	Active
RAZOR Single-Use Acetabular Reamer	1000-0048	FDA UDI	Class I	Active
RAZOR Single-Use Acetabular Reamer	1001-0063	FDA UDI	Class I	Active
RAZOR Single-Use Acetabular Reamer	1001-0054	FDA UDI	Class I	Active
RAZOR Single-Use Acetabular Reamer	1000-0051	FDA UDI	Class I	Active
RAZOR Single-Use Acetabular Reamer	1001-0062	FDA UDI	Class I	Active
RAZOR Calcar Planer	1102-0038-P	FDA UDI	Class I	Active
RAZOR Single-Use Acetabular Reamer	1001-0049	FDA UDI	Class I	Active
RAZOR Single-Use Acetabular Reamer	1001-0047	FDA UDI	Class I	Active
RAZOR Single-Use Acetabular Reamer	1000-0054	FDA UDI	Class I	Active
RAZOR Reusable Adapter for Razor Acetabular Reamer	1003-0011	FDA UDI	Class I	Active
RAZOR Single-Use Acetabular Reamer	1000-0053	FDA UDI	Class I	Active
RAZOR Single-Use Acetabular Reamer	1001-0051	FDA UDI	Class I	Active
RAZOR Single-Use Acetabular Reamer	1000-0057	FDA UDI	Class I	Active
RAZOR Single-Use Acetabular Reamer	1000-0049	FDA UDI	Class I	Active
RAZOR Single-Use Acetabular Reamer	1000-0055	FDA UDI	Class I	Active
RAZOR Single-Use Acetabular Reamer	1001-0057	FDA UDI	Class I	Active
RAZOR Single-Use Acetabular Reamer	1001-0052	FDA UDI	Class I	Active
RAZOR Single-Use Acetabular Reamer	1000-0059	FDA UDI	Class I	Active
RAZOR Single-Use Acetabular Reamer	1001-0058	FDA UDI	Class I	Active
RAZOR Single-Use Acetabular Reamer	1000-0050	FDA UDI	Class I	Active
RAZOR Single-Use Acetabular Reamer	1001-0060	FDA UDI	Class I	Active
RAZOR Single-Use Acetabular Reamer	1001-0048	FDA UDI	Class I	Active
RAZOR Single-Use Acetabular Reamer	1000-0060	FDA UDI	Class I	Active
RAZOR Single-Use Acetabular Reamer	1001-0061	FDA UDI	Class I	Active
RAZOR Reusable Adapter for Razor Acetabular Reamer	1003-0014	FDA UDI	Class I	Active
RAZOR Single-Use Acetabular Reamer	1001-0053	FDA UDI	Class I	Active
RAZOR Single-Use Acetabular Reamer	1001-0066	FDA UDI	Class I	Active
RAZOR Single-Use Acetabular Reamer	1001-0065	FDA UDI	Class I	Active
RAZOR Single-Use Acetabular Reamer	1000-0058	FDA UDI	Class I	Active

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