Question 1

What types of medical devices does Shanghai Kinetic Medical Co., Ltd. manufacture?

Accepted Answer

Shanghai Kinetic Medical Co., Ltd. produces a range of orthopaedic and surgical equipment. Their primary offerings include bone access channel kits, balloon kyphoplasty kits, inflatable bone tamps, orthopaedic cement preparation and delivery kits, bone grafting cannulas, and single-use balloon inflators. Additionally, they manufacture surgical instruments such as drills, guide wires, access needles, balloon catheters, and periodontal disease-associated nucleic acid test kits.

Question 2

Where is Shanghai Kinetic Medical Co., Ltd. located?

Accepted Answer

Shanghai Kinetic Medical Co., Ltd. is based in China. This location information is provided based on the company's official registration data, which identifies the country of origin as CN.

Question 3

How are the devices from Shanghai Kinetic Medical Co., Ltd. classified?

Accepted Answer

The devices manufactured by Shanghai Kinetic Medical Co., Ltd. are categorized under Class I, Class II, and Class IIa regulatory classifications. These classifications reflect the varying levels of risk and regulatory requirements associated with the specific medical devices in their product portfolio.

Question 4

Which regulatory registries list the devices from Shanghai Kinetic Medical Co., Ltd.?

Accepted Answer

The devices produced by Shanghai Kinetic Medical Co., Ltd. are listed in the EUDAMED database, the FDA 510(k) clearance database, and the FDA UDI database. These listings indicate that the company's products are tracked within these specific international and national regulatory systems.

Device	Model / Reference	Registries	Class	Status
Puncture Needle	FG3008	EUDAMEDFDA UDI	Class IIa	Active
Medical Balloon Catheter Syringe Pump	FG4003	EUDAMEDFDA UDI	Class I	Active
Kyphoplasty Tool Kit	FG2002	EUDAMEDFDA UDI	Class IIa	Active
Bone Cement Injection Gun	SD8101	EUDAMEDFDA UDI	Class I	Active
Balloon Catheter	LC102-2520	EUDAMED	Class IIa	Active
Bone Filler Device	FG2500	EUDAMEDFDA UDI	Class IIa	Active
Arthroscopic Cannula	AC5572O	EUDAMED	Class IIa	Active
Arthroscopic Cannula	AC8590O	EUDAMED	Class IIa	Active
Kmc Kyphoplasty System	K113742	FDA 510(k)	Class II	Active
Biopsy Instrument	BC1101	EUDAMED	Class IIa	Active
Puncture Needle	FG3002	EUDAMEDFDA UDI	Class IIa	Active
Bone Cement Injection Gun	SD8102	EUDAMEDFDA UDI	Class I	Active
Dilator	FG2400	EUDAMEDFDA UDI	Class IIa	Active
Kyphoplasty Tool Kit	FG2001	EUDAMEDFDA UDI	Class IIa	Active
Arthroscopic Cannula	AC8572O	EUDAMED	Class IIa	Active
Puncture Needle	FG3003	EUDAMEDFDA UDI	Class IIa	Active
Bone Drill	FG2700	EUDAMED	Class IIa	Active
Arthroscopic Cannula	AC8545O	EUDAMED	Class IIa	Active
Locking Syringe	FG4200	EUDAMED	Class I	Active
Puncture Needle	FG3011	EUDAMEDFDA UDI	Class IIa	Active
Kyphoplasty System	FG0007-20	EUDAMEDFDA UDI	Class IIa	Active
Medical Balloon Catheter Syringe Pump	FG4001	EUDAMEDFDA UDI	Class I	Active
Bone Drill	FG2701	EUDAMED	Class IIa	Active
Medical Balloon Catheter Syringe Pump	FG4203	EUDAMED	Class I	Active
Guide Wire	FG2300	EUDAMED	Class IIa	Active
Puncture Needle	FG3009	EUDAMEDFDA UDI	Class IIa	Active
Cannula	FG2200	EUDAMEDFDA UDI	Class IIa	Active
Kyphoplasty System	FG0005-15	EUDAMEDFDA UDI	Class IIa	Active
Puncture Needle	FG3004	EUDAMEDFDA UDI	Class IIa	Active
Cannula	FG2203	EUDAMED	Class IIa	Active
Balloon Catheter	FG1001-10	EUDAMEDFDA UDI	Class IIa	Active
Balloon Catheter	FB2015	EUDAMED	Class IIa	Active
Balloon Catheter	FG1001-20	EUDAMEDFDA UDI	Class IIa	Active
Puncture Needle	FG3006	EUDAMEDFDA UDI	Class IIa	Active
Drill	FG2102	EUDAMED	Class IIa	Active
Arthroscopic Cannula	AC7072O	EUDAMED	Class IIa	Active
Bone Filler Device	FG2501	EUDAMEDFDA UDI	Class IIa	Active
Arthroscopic Cannula	AC5545O	EUDAMED	Class IIa	Active
Puncture Needle	FG3007	EUDAMEDFDA UDI	Class IIa	Active
Bone Cement Delivery System	FG8115	EUDAMEDFDA UDI	Class I	Active
Kyphoplasty System	FG0005-20	EUDAMEDFDA UDI	Class IIa	Active
Balloon Catheter	SS101-2010	EUDAMED	Class IIa	Active
Puncture Needle	FG3001	EUDAMEDFDA UDI	Class IIa	Active
Curet	FG9001	EUDAMEDFDA UDI	Class IIa	Active
Bone Filler Device	FG2502	EUDAMED	Class IIa	Active
Vertebral Osteotome	V01103	EUDAMEDFDA UDI	Class IIa	Active
Kyphoplasty Multifunctional Tool	FG5100	EUDAMED	Class IIa	Active
Balloon Catheter	FG1001-15	EUDAMEDFDA UDI	Class IIa	Active
Bone Cement Injection Gun	SD8103	EUDAMEDFDA UDI	Class I	Active
Puncture Needle	FG3010	EUDAMEDFDA UDI	Class IIa	Active

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