Question 1

What types of medical devices does Shukla Medical manufacture?

Accepted Answer

Shukla Medical manufactures reusable surgical screwdrivers, reusable and single-use orthopaedic implant inserters and extractors, single-use extractors, single-use screw extractors, single-use osteotome blades, reusable implant-instrument extension adaptors, reusable instrument trays, and reusable surgical torque wrenches. These devices are used in orthopaedic procedures for the insertion, removal, and manipulation of implants and instruments, as stated in the provided summary.

Question 2

Where is Shukla Medical based?

Accepted Answer

Shukla Medical is based in the United States, as explicitly stated in the SUMMARY section of the device data, which confirms the company's country of origin as US.

Question 3

In which regulatory registry are Shukla Medical's devices listed?

Accepted Answer

Shukla Medical's devices are listed in the FDA's Unique Device Identification (fda_udi) system, as specified in the DEVICE CLASSES and LISTED IN fields and reiterated in the SUMMARY, which states all devices are listed in the FDA's UDI system.

Question 4

How are Shukla Medical's devices classified under regulatory frameworks?

Accepted Answer

All devices manufactured by Shukla Medical are classified as Class I medical devices, as clearly stated in the DEVICE CLASSES field and confirmed in the SUMMARY, which notes that all devices are Class I and listed in the FDA's UDI system.

Device	Model / Reference	Registries	Class	Status
Shukla Shoulder S9SHLDR	STP069-02	FDA UDI	Class I	Active
Shukla Xtract-All Spine MKS1031 (Legacy)	MBT138	FDA UDI	Class I	Active
Shukla Spine-TL S9SPINE-TL, S9SPINE-CTL	SDR766C	FDA UDI	Class I	Active
Shukla Xtract-All Spine MKS1031 (Legacy)	MBT184	FDA UDI	Class I	Active
Shukla Winquist 3 - MKS1017	WIN4	FDA UDI	Class I	Active
Shukla Spine-TL S9SPINE-TL, Shukla Spine-CTL S9SPINE-CTL	SDR858	FDA UDI	Class I	Active
Shukla Spine-TL S9SPINE-TL, Shukla Spine-CTL S9SPINE-CTL	SDR764	FDA UDI	Class I	Active
Shukla Xtract-All Spine MKS1031 (Legacy)	MBT119	FDA UDI	Class I	Active
Shukla Xtract-All Spine MKS1031 (Legacy)	MBT126	FDA UDI	Class I	Active
Shukla Shoulder S9SHLDR	SBD132	FDA UDI	Class I	Active
Shukla Spine-TL S9SPINE-TL, S9SPINE-CTL	SDR880	FDA UDI	Class I	Active
Shukla Spine-TL S9SPINE-TL, Shukla Spine-CTL S9SPINE-CTL	SDR712	FDA UDI	Class I	Active
Shukla Xtract-All Spine MKS1031 (Legacy)	MBT118	FDA UDI	Class I	Active
Shukla Shoulder Blade S9SHLDR-BLADE	SCS062	FDA UDI	Class I	Active
Shukla Trephine S9TREPHINE	STR001-06-SP	FDA UDI	Class I	Active
Shukla Shoulder S9SHLDR	SHN031	FDA UDI	Class I	Active
Shukla Trephine S9TREPHINE	STR001-12	FDA UDI	Class I	Active
Removal System, Screw, Legacy, Broken & Stripped Extractors MKS1022	TP345-M01	FDA UDI	Class I	Active
Shukla Spine-TL S9SPINE-TL, Shukla Spine-CTL S9SPINE-CTL	SDR805	FDA UDI	Class I	Active
Shukla Xtract-All Spine MKS1031 (Legacy)	MBT115	FDA UDI	Class I	Active
Shukla Winquist 3 - MKS1017	WIN1	FDA UDI	Class I	Active
Shukla Shoulder S9SHLDR	STP080	FDA UDI	Class I	Active
Shukla Spine-TL S9SPINE-TL, Shukla Spine-CTL S9SPINE-CTL	SDR731	FDA UDI	Class I	Active
Shukla Shoulder S9SHLDR	SXT037-06	FDA UDI	Class I	Active
Shukla S9SPINE-TL, S9SPINE-CTL, S9SPINE-C, MKS1017, MKS1031	MHRS0311	FDA UDI	Class I	Active
Shukla Winquist 3 - MKS1017	MDS060200	FDA UDI	Class I	Active
Shukla Trephine S9TREPHINE	STR001-13-SP	FDA UDI	Class I	Active
Shukla Shoulder Blade S9SHLDR-BLADE	SBLDFLAT-12	FDA UDI	Class I	Active
Shukla Winquist 3 - MKS1017	WIN22	FDA UDI	Class I	Active
Shukla Shoulder S9SHLDR	SXT037-03	FDA UDI	Class I	Active
Shukla Trephine S9TREPHINE	STR001-13	FDA UDI	Class I	Active

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