SOUTHEASTERN TECHNOLOGY dba Autocam Medical

FDA Device Registration & Listing · Murfreesboro, TN, US · Registration 1057425

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1057425
FEI Number
1000221916
Entity Name
SOUTHEASTERN TECHNOLOGY dba Autocam Medical
City/State/Country
Murfreesboro, TN, US
Establishment Address
905 INDUSTRIAL DR, Murfreesboro, TN 37129, 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
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

CLAW® II A PLATE LARGE LT

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-07
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-07
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2015-04-10
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2015-05-01
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2015-05-01
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2015-05-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-11-01
GAC Rasp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2015-05-01
OYK Ankle Arthroplasty Implantation System Orthopedic Class 2 888.3110 2015-05-01
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 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 2015-05-01
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2015-05-01
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-04-10
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2015-04-10
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2015-05-01
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2015-05-01
DZN Instruments, Dental Hand Dental Class 1 872.4565 2015-05-01
HWD Starter, Bone Screw Orthopedic Class 1 888.4540 2015-04-10
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
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2021-06-15
EJB Handle, Instrument, Dental Dental Class 1 872.4565 2015-05-01
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2015-05-01
HWA Impactor Orthopedic Class 1 888.4540 2015-04-13
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2021-06-02
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-05-01
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2015-05-01
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-05-01
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2015-05-01
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2015-04-10
HTX Rongeur Orthopedic Class 1 888.4540 2015-05-01
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 2015-04-13
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-03
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-03
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-03
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-03
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-07-20
JEY Plate, Bone Dental Class 2 872.4760 2018-07-20
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-31
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-05-01
MQN External Mandibular Fixator And/Or Distractor Dental Class 2 872.4760 2015-05-01
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2013-01-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-07
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2016-03-09
HTD Forceps General, Plastic Surgery Class 1 878.4800 2015-05-01
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2017-04-02
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-04
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2025-03-05
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2015-05-01
HWW Countersink Orthopedic Class 1 888.4540 2013-01-18
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
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2017-04-02
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2020-01-14
HXB Probe Orthopedic Class 1 888.4540 2015-04-10
HWX Tap, Bone Orthopedic Class 1 888.4540 2015-04-10
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-05-01
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2015-05-01
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-05-01
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2015-05-01
HTW Bit, Drill Orthopedic Class 1 888.4540 2013-01-18
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-11-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-11-01
GFF Bur, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4820 2015-05-01
GEE Brush, Biopsy, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2015-05-01
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2015-05-01
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2015-05-01
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2013-01-07
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2019-12-12
HWT Template Orthopedic Class 1 888.4800 2015-05-01
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2021-06-02
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-04-10
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2015-04-10
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2015-04-10
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-04-10
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-05-01
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2015-04-10
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-04
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2013-01-31
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2013-01-18
HXC Wrench Orthopedic Class 1 888.4540 2013-01-18
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2015-05-01
HTO Reamer Orthopedic Class 1 888.4540 2013-01-18
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2015-05-01
NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2015-05-01
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2015-05-01
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3540 2015-05-01
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2015-05-01
KRQ Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3550 2015-05-01
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2015-05-01
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2015-05-01
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-12-02
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2013-01-07
GAD Retractor General, Plastic Surgery Class 1 878.4800 2015-05-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-07
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-07
HWB Extractor Orthopedic Class 1 888.4540 2015-05-01
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2015-04-10
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
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-09-13
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-09-10
FZS Curette, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2015-05-01
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-31
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-05-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-05-01
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2017-04-02
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2015-05-01
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-04
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
HWJ Awl Orthopedic Class 1 888.4540 2015-04-10
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2015-05-01
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2015-05-01
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 2015-05-01
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2015-05-01
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2015-05-01
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
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
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2015-05-01
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2015-05-01
FWZ Operating Room Accessories Table Tray General, Plastic Surgery Class 1 878.4950 2020-04-01
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2015-05-01
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2015-05-01
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2015-05-01
HXG Tamp Orthopedic Class 1 888.4540 2015-04-13
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2015-05-01
HWR Driver, Prosthesis Orthopedic Class 1 888.4540 2013-01-22

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
3010047402 AUTOCAM MEDICAL Kentwood, MI, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K042598 Zimmer, Inc. PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES 2004-10-29
K190842 Jiangsu Trauhui Medical Instrument Co., Ltd. Comus Locking Plate systems 2020-02-03
K130510 Arthrex, Inc. ARTHREX COMPRESSION PLATES 2013-09-25
K202803 Newclip Technics Activmotion S DTO 2021-12-16
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0034-2022 Flower Orthopedics Corporation 2
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1057425. Last updated year: 2026. Please use registration number 1057425 when referencing this establishment in official correspondence.
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