ABLE MEDICAL DEVICES

FDA Device Registration & Listing · Gwinn, MI, US · Registration 3014680795

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
3014680795
FEI Number
3014680795
Entity Name
ABLE MEDICAL DEVICES
City/State/Country
Gwinn, MI, US
Establishment Address
512 Fourth Street, Gwinn, MI 49841, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Able Medical Devices (Owner Number: 10058122)
Owner / Operator Contact Address
512 Fourth Street, Gwinn, MI 49841, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Valkyrie Thoracic Fixation System Valkyrie Rib Thoracic Fixation System Valkyrie Thoracic Fixation System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2023-12-28
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2021-11-21
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2024-12-12
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2024-12-12
HXG Tamp Orthopedic Class 1 888.4540 2019-03-18
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-12-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-12-08
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2022-12-08
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2022-12-08
PLR Spinal Vertebral Body Replacement Device - Cervical Orthopedic Class 2 888.3060 2021-11-21
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2021-11-21
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-12-12
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2021-11-21
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2021-11-21
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2021-11-21
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2023-12-28
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-12-18
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-03-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-03-12
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-12-08
HTW Bit, Drill Orthopedic Class 1 888.4540 2019-11-20
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2018-11-20
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2024-12-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-12-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-12-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-12-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-12-12
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2021-11-21
HXC Wrench Orthopedic Class 1 888.4540 2025-12-18
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2021-11-21
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2021-11-21
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-12-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2024-12-16
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-12-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-12-15
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-12-15
PLR Spinal Vertebral Body Replacement Device - Cervical Orthopedic Class 2 888.3060 2021-11-21
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2021-11-21
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2020-12-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-12-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-12-12
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-09-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-09-22
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2019-03-18
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-12-12
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2024-12-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-12-12
LXI Guide, Drill, Ligament General, Plastic Surgery Class 1 878.4820 2025-12-18
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-06-26
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-06-26
HXX Screwdriver Orthopedic Class 1 888.4540 2019-03-18
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2022-04-19
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2022-04-19
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-12-12
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-12-12
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-12-12
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2021-11-21
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2025-12-18
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2025-12-18
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2021-09-23
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2023-12-28
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-12-28
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2023-12-28
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-11-21
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2021-11-21
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2021-11-21
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-12-12
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-12-18
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-12-18
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-12-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-12-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-12-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-12-18
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-12-18
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-12-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-12-12
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2021-09-23
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2021-11-21
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-11-21
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2020-12-22
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 2023-12-28
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-12-12
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2024-12-12
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2024-12-12
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2023-12-28
OZI Internal Hinged Elbow Fixator Orthopedic Class 2 888.3030 2023-12-28
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-11-21
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-12-18
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-12-18
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2022-04-19
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-11-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-12-12
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-12-28
OZI Internal Hinged Elbow Fixator Orthopedic Class 2 888.3030 2023-12-28
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2023-12-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-12-28
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2021-11-21
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2021-11-21
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-12-18
GAD Retractor General, Plastic Surgery Class 1 878.4800 2022-12-08
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2020-12-22
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-12-18
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2025-12-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-12-08
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2022-12-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-12-12
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2023-12-28
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2022-12-08
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2022-12-08
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-02-08

Official Correspondent

Halie Gibson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Able Medical Devices
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3038776593 Able Medical Devices Marquette, MI, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K032752 R&B Surgical Solutions, LLC R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM 2003-12-03
K062643 Life Spine KINETIC ANTERIOR CERVICAL PLATE 2006-11-16
K141345 Tornier S.A.S. AEQUALIS FX2 2014-11-18
K260601 Blue Belt Technologies, Inc. REAL INTELLIGENCE™ CORI™ 2026-03-26
K142269 Reliance Medical Systems, LLC Reliance Cervical IBF System 2015-06-09

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0036-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013 Medtronic Sofamor Danek USA Inc 2
PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0040-05 Zimmer Spine, Inc. 2
ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.
Z-0041-2024 Blue Belt Technologies, Inc 2
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014680795. Last updated year: 2026. Please use registration number 3014680795 when referencing this establishment in official correspondence.
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