Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007583504

FEI Number

3007583504

Entity Name

Sanbor Medical Xiamen, Inc.

City/State/Country

Xiamen Fujian, CN

Establishment Address

1776 Lv Ling Road, Xiamen Fujian 361009, CN

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Sanbor Medical (Owner Number: 10028522)

Owner / Operator Contact Address

7584 Morris Court, Suite 218, Allentown, PA 18106, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K160014

PMA Number

N/A

All Registered Proprietary Names

Radial Head SherpaPak CTS Suction Easy Radial Head PancreasPak Bipolar Needle Taylor Bunion PMD Pulse Oximeter Lag Screw sizer Wright Medical Staple PMD Weight Scale PMD Blood Pressure Monitor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2019-10-29
MSB	System And Accessories, Isolated Heart, Transport And Preservation	Gastroenterology, Urology	Class 2	876.5880	2025-09-26
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2009-05-27
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-10-26
HWT	Template	Orthopedic	Class 1	888.4800	2019-10-24
KDN	System, Perfusion, Kidney	Gastroenterology, Urology	Class 2	876.5880	2025-09-26
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-08-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-11-18
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2018-05-07
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2021-01-20
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-11-20
FRI	Scale, Stand-On, Patient	General Hospital	Class 1	880.2700	2018-05-07
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2018-05-07

Official Correspondent

Wayne Meng

US Agent Details

Wayne Meng Email: wmeng@RemetricHealth.com Phone: (610) 5308500

Related Public Records

Same Entity

Sanbor Medical

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007113169	Sanbor Medical	Allentown, PA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K153770	In2bones Sas	OS2(R)-VP Varisation Staple	2016-03-21
K013575	Organ Recovery Systems, Inc.	KPS-I, THE KIDNEY PERFUSION SOLUTION	2002-01-25
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

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3038207124	NATIVE ORTHOPAEDICS	Providence, RI, US
3027516563	STAR SPORTS MEDICINE CO., LTD.	Beijing, CN
3021574846	3D LOGICS LLC	Hillsboro, OR, US
3030089866	ORTOLOG MEDIKAL SANAYI VE TICARET A.S.	Yenimahalle Ankara, TR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007583504. Last updated year: 2026. Please use registration number 3007583504 when referencing this establishment in official correspondence.