Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1225838

FEI Number

3001644153

Entity Name

AUTOCAM MEDICAL

City/State/Country

Plymouth, MA, US

Establishment Address

24 ALDRIN ROAD, Plymouth, MA 02360, 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

Arthrex - LOW PROFILE PLATE & SCREW SYSTEM - tubular plates - Autocam Medical - Plymouth CLAW® II A PLATE LARGE LT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-01-04
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-04
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-04
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-01-04
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2013-01-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-12-23
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-12-23
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-01-18
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-12-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-12-15
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2020-12-15
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-12-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-12-15
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-04-13
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-12-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-12-15
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-12-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-05-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-03-03
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-03-03
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-02-24
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2013-01-22
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2013-01-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-12-15
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-12-15
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-04
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-04
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-01-04
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-01-07
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-01-07
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-02-24
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2013-01-22
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-01-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-01-26
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-01-04
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	Class 2	882.4800	2013-01-04

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
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
K032604	Co-Ligne AG	GII SPINAL FIXATION SYSTEM	2004-01-20
K964304	Osteonics Corp.	OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY	1997-01-17
K963639	Acromed Corp.	ACROMED PEDICLE SCREW	1996-11-14
K012175	Encore Orthopedics, Inc.	PASS SPINAL SYSTEM	2001-07-31
K163363	Surgtech, Inc.	SurgTech Thoracolumbosacral (TLS) Posterior Fixation System	2017-04-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Z-0027-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Z-0028-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L
Z-0029-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL
Z-0030-2011	Zimmer Inc.	2	SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1225838. Last updated year: 2026. Please use registration number 1225838 when referencing this establishment in official correspondence.