AMERICAN MANUFACTURING AND ENGINEERING

FDA Device Registration & Listing · Montgomeryville, PA, US · Registration 3010197224

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
3010197224
FEI Number
3010197224
Entity Name
AMERICAN MANUFACTURING AND ENGINEERING
City/State/Country
Montgomeryville, PA, US
Establishment Address
506 Stump Rd, Montgomeryville, PA 18936, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
American Manufacturing and Engineering (Owner Number: 10043997)
Owner / Operator Contact Address
506 Stump Road, Montgomeryville, PA 18936, US
Initial Importer Flag
N
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
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2023-01-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-04-16
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-04-16
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-04-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-04-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2023-01-16
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2023-01-16
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2023-01-16
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-01-16
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-01-16
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-16
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-01-16
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2025-01-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2023-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2023-01-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2023-01-16
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-01-16
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2023-01-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-04-16
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-04-16
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-04-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-04-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-04-16
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2023-01-16
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2023-01-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2023-01-16
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-16
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-04-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-04-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-04-16
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-04-16
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-04-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-04-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-04-16
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-04-16
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2023-01-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-01-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-01-16
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-01-16
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-16
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-01-16
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2023-01-16
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-01-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-01-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-01-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2023-01-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2023-01-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-01-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-01-16
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-01-16
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2023-01-16
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-04-16
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-01-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2023-01-16
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2023-01-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2023-01-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2023-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2023-01-16
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2023-01-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2023-01-16
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2023-01-16
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-02-09

Official Correspondent

Christine Knechel

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

American Manufacturing and Engineering
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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
K163363 Surgtech, Inc. SurgTech Thoracolumbosacral (TLS) Posterior Fixation System 2017-04-05
K252461 Spinal Resources, Inc. Swedge™ Pedicle Screw Fixation System Bezier Rod 2026-01-13
K140696 Pioneer Surgical Technology, Inc. STREAMLINE TL SPINAL FIXATION SYSTEM 2014-04-10

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-0001-2013 Synthes USA HQ, Inc. 2
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010197224. Last updated year: 2026. Please use registration number 3010197224 when referencing this establishment in official correspondence.
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