Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010047402

FEI Number

3010047402

Entity Name

AUTOCAM MEDICAL

City/State/Country

Kentwood, MI, US

Establishment Address

4152 (4162) East Paris Ave SE, Kentwood, MI 49512, US

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
HWB	Extractor	Orthopedic	Class 1	888.4540	2015-05-01
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-01-31
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2013-01-31
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2013-01-31
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2013-01-07
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2022-02-23
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2014-08-19
HWT	Template	Orthopedic	Class 1	888.4800	2015-05-01
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-11-01
HXC	Wrench	Orthopedic	Class 1	888.4540	2013-01-18
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3540	2015-05-01
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2015-05-01
NPJ	Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2015-05-01
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2015-05-01
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-11-01
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2013-01-22
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2021-07-28
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-01-07
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-01-07
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2020-01-21
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2020-01-21
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-01-07
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2013-01-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-08-01
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-08-01
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2020-09-23
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2013-01-31
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2018-01-31
HWW	Countersink	Orthopedic	Class 1	888.4540	2013-01-18
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2021-07-28
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2015-05-01
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-01-18
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2023-05-23
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2013-01-18
MLZ	Vitrectomy, Instrument Cutter	Ophthalmic	Class 2	886.4150	2015-02-26
HQR	Apparatus, Cautery, Radiofrequency, Ac-Powered	Ophthalmic	Class 2	886.4100	2015-02-26
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2015-02-26
KYB	Lens, Guide, Intraocular	Ophthalmic	Class 1	886.4300	2015-02-26

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
3013564228	Autocam Medical Devices (Suzhou) Co. Ltd.	Suzhou Jiangsu, CN
1225838	AUTOCAM MEDICAL	Plymouth, MA, 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-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018	MicroPort Orthopedics Inc.	2	MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010047402. Last updated year: 2026. Please use registration number 3010047402 when referencing this establishment in official correspondence.