Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013564228

FEI Number

3013564228

Entity Name

Autocam Medical Devices (Suzhou) Co. Ltd.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

3A Xinxing Industrial Square, No.78 Xinglin St., Suzhou Jiangsu 215026, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Autocam Medical (Owner Number: 9034301)

Owner / Operator Contact Address

3607 Broadmoor Avenue SE, Kentwood, MI 49512, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2021-07-28
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-01-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-02-13
ORY	Tongue Suspension System	Dental	Class 2	872.5570	2021-07-06
HWB	Extractor	Orthopedic	Class 1	888.4540	2015-05-01

Official Correspondent

No official correspondent registered.

US Agent Details

Greg Coberly Business: Autocam Medical Devices LLC Email: gcoberly@autocam-medical.com Phone: (616) 5418080

Related Public Records

Same Entity

Autocam 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
1225838	AUTOCAM MEDICAL	Plymouth, MA, US
3010047402	AUTOCAM MEDICAL	Kentwood, MI, US
1057425	SOUTHEASTERN TECHNOLOGY dba Autocam Medical	Murfreesboro, TN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08
K063244	Arc Surgical, LLC	ARC SURGICAL BONE REDUCTION SCREW	2006-12-27
K972722	Orthopedic Designs, Inc.	ULTIMATE COMPRESSION SCREW SYSTEM	1998-01-23
K192974	Tyber Medical, LLC	Tyber Medical Trauma Screw	2020-01-08
K082949	OrthoPediatrics Corp.	ORTHOPEDIATRICS BONE SCREWS	2008-11-25

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.

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3010673850	MK medical GmbH	Emmingen-Liptingen Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013564228. Last updated year: 2026. Please use registration number 3013564228 when referencing this establishment in official correspondence.