Question 1

What types of medical devices does Hankil Tech Medical Co., Ltd. manufacture?

Accepted Answer

Hankil Tech Medical Co., Ltd. specializes in orthopaedic fixation devices and reusable surgical tools. Their portfolio includes non-bioabsorbable orthopaedic fixation plates, non-sliding bone screws, and anatomical locking trauma systems for stabilizing bones. Additionally, they produce reusable surgical instruments like torque-limiting handles, fluted drill bits, depth gauges, drill guides, manual orthopaedic benders, and screwdrivers. These devices are designed for orthopaedic procedures, particularly fracture fixation and bone stabilization.

Question 2

Where is Hankil Tech Medical Co., Ltd. based?

Accepted Answer

Hankil Tech Medical Co., Ltd. is headquartered in South Korea. The company’s location in South Korea influences its regulatory compliance processes, particularly for devices marketed in global markets like the EU and the US.

Question 3

Which regulatory registries list Hankil Tech Medical Co., Ltd.’s devices?

Accepted Answer

Hankil Tech Medical Co., Ltd.’s devices are listed in multiple global regulatory databases, including the EU’s eudamed registry and the US FDA’s 510(k) premarket notification system and UDI (Unique Device Identification) database. These listings reflect compliance with European and US medical device regulations, ensuring traceability and transparency for authorized products.

Question 4

How are Hankil Tech Medical Co., Ltd.’s devices classified under global regulations?

Accepted Answer

Hankil Tech Medical Co., Ltd.’s devices fall into different risk-based classification categories depending on their intended use and potential risk to patients. Their portfolio includes Class I devices (generally low-risk, like some reusable surgical tools), Class II devices (moderate-risk, such as orthopaedic fixation plates and screws), and Class IIb devices (higher-risk, including specialized anatomical locking trauma systems). Classification determines regulatory requirements like design controls, clinical evaluations, and post-market surveillance.

Question 5

Why do some of Hankil Tech Medical Co., Ltd.’s devices appear with repeated names in the example list?

Accepted Answer

The repeated device names in the example list (e.g., *HKT Anatomical Locking Trauma System*) reflect variations in product models, part numbers, or slight design adaptations (such as different sizes or configurations) under the same core product line. Each entry corresponds to a distinct UDI (Unique Device Identifier), ensuring individual tracking for regulatory compliance and traceability, even when the core function remains the same.

Device	Model / Reference	Registries	Class	Status
16206-01050; 60-041; 60-042	60-041	FDA UDI	Class I	Active
HKT Anatomical Lciking Trauma System	12203-35030	FDA UDI	Class II	Active
HKT Anatomical Lciking Trauma System	11424-92020	FDA UDI	Class II	Active
HKT Anatomical Locking Trauma System	12203-35028	FDA UDI	Class II	Active
HKT Anatomical Lciking Trauma System	16104-01004	FDA UDI	Class I	Active
HKT Anatomical Lciking Trauma System	12203-35034	FDA UDI	Class II	Active
HKT Anatomical Locking Trauma System	16211-25160	FDA UDI	Class I	Active
16205-01050; 16205-01110; 60-025	16205-01110	FDA UDI	Class I	Active
HKT Anatomical Locking Trauma System	16203-04030	FDA UDI	Class I	Active
HKT Anatomical Lciking Trauma System	47-015	FDA UDI	Class I	Active
HKT Anatomical Locking Trauma System	16202-30140	FDA UDI	Class I	Active
HKT Anatomical Locking Trauma System	12203-35024	FDA UDI	Class II	Active
HKT Anatomical Lciking Trauma System	11424-92035	FDA UDI	Class II	Active
HKT Anatomical Lciking Trauma System	16214-11015	FDA UDI	Class I	Active
HKT Anatomical Locking Trauma System	11424-92015	FDA UDI	Class II	Active
HKT Anatomical Lciking Trauma System	11424-92050	FDA UDI	Class II	Active
HKT Anatomical Lciking Trauma System	11424-92040	FDA UDI	Class II	Active
HKT Anatomical Lciking Trauma System	16203-03031	FDA UDI	Class I	Active
HKT Anatomical Locking Trauma System	K254249	FDA 510(k)	Class II	Active
HKT Anatomical Locking Trauma System	K231213	FDA 510(k)	Class II	Active
Anatomic Midshaft Forearm Plate, A-type	1025-12004	EUDAMED	Class IIb	Active

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