Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010606097

FEI Number

3010606097

Entity Name

JIANGSU IDEAL MEDICAL SCIENCE & TECHNOLOGY CO., LTD.

City/State/Country

Zhangjiagang City Jiangsu, CN

Establishment Address

East Area, Jinfeng Industry Park, Zhangjiagang City Jiangsu 215625, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Jiangsu Ideal Medical Science & Technology Co., Ltd. (Owner Number: 10051336)

Owner / Operator Contact Address

East Area, Jinfeng Industry Park, Zhangjiagang City, CN-JS 215625, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ideal Ideal AxCess® Expandable Interbody System Bone Curette

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2016-03-03
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2016-03-03
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2016-03-03
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-09-17
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2025-12-07

Official Correspondent

Helen Zhang

US Agent Details

Jim MacNee Business: USDeviceAgent.com Email: jmacnee@usdeviceagent.com Phone: (951) 8486626

Related Public Records

Same Entity

Jiangsu Ideal Medical Science & Technology 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
K040336	Synthes (Usa)	SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM	2004-04-12
K083648	Efratgo, Ltd. HI Tech Bio-Surgical	GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL	2009-05-14
K192312	Zimmer GmbH	Zimmer Natural Nail System Cephalomedullary Nails	2019-10-11
K002057	Biomet Orthopedics, Inc.	BROOKER TIBIA NAILS	2000-10-04
K032604	Co-Ligne AG	GII SPINAL FIXATION SYSTEM	2004-01-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2012	X Spine Systems Inc	1	Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 The Axle Torque Driver Handle is used to lock the set screw into the locking plate.

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3006783837	STRUCTURE MEDICAL, LLC.	Naples, FL, US
3009732568	BGS BETA-GAMMA-SERVICE GMBH & CO KG	Wiehl North Rhine-Westphalia, DE
1424263	Isomedix Operations, Inc.	Libertyville, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010606097. Last updated year: 2026. Please use registration number 3010606097 when referencing this establishment in official correspondence.