Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010071016

FEI Number

3010071016

Entity Name

SHANGHAI KiNETIC MEDICAL CO LTD

City/State/Country

Shanghai, CN

Establishment Address

2F, No.23 Building, 528 Ruiqing Road, East Zhangjiang High-Tech Park;, No.508, Tianchen Rd., Xianghuaqiao Street, Qingpu, Shanghai 201201, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Shanghai Kinetic Medical Co LTD (Owner Number: 10050980)

Owner / Operator Contact Address

2F, No.23 Building, 528 Ruiqing Road, East Zhangjiang High-Tech Park, East Zhangjiang, CN-SH 201201, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sterilization Tray Kerrison Working Port Dilator Cannula Dissector KMC Kyphoplasty System Pusher/Extender Nerve Probe Handle One-shot Bone Drill Freer Elevator K-wire Chisel

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2025-11-22
HTX	Rongeur	Orthopedic	Class 1	888.4540	2024-11-05
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-11-05
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-11-05
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2016-01-22
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2016-01-22
HXO	Pusher, Socket	Orthopedic	Class 1	888.4540	2025-09-19
HXB	Probe	Orthopedic	Class 1	888.4540	2024-11-05
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2025-09-19
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2020-05-14
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-11-05
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2026-02-12
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2024-11-05

Official Correspondent

Halley Feng

US Agent Details

Gregory Mathison Business: Regulatory Strategies, Inc. Email: gmathison@att.net Phone: (218) 3871559

Related Public Records

Same Entity

Shanghai Kinetic Medical Co LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
Z-0017-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle Catalog Number: 4621

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010071016. Last updated year: 2026. Please use registration number 3010071016 when referencing this establishment in official correspondence.