AVALIGN INTEGRATED MEDICAL SOLUTIONS, INC

FDA Device Registration & Listing · Mentor, OH, US · Registration 1527105

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
1527105
FEI Number
1000069183
Entity Name
AVALIGN INTEGRATED MEDICAL SOLUTIONS, INC
City/State/Country
Mentor, OH, US
Establishment Address
7124 Industrial Park Blvd, Mentor, OH 44060, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Avalign Technologies (Owner Number: 10051835)
Owner / Operator Contact Address
110275 W. Higgins Rd, Suite 920, Rosemont, IL 60018, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Mini Polyaxial Bone Screw GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-06-22
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-06-22
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-06-22
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-06-22
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-06-22
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2026-01-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-11-15
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-11-15
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2019-06-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-06-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-06-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-06-22
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-06-22
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-01-30
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-01-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-06-22
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2019-06-22
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-06-22
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-06-22
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-06-22
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-06-22
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-06-22
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-06-22
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-06-22
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-01-30
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-06-22
OBT Plate, Bone, Growth Control, Pediatric, Epiphysiodesis Orthopedic Class 2 888.3030 2019-06-22
IQK Orthosis, Cervical Physical Medicine Class 1 890.3490 2019-06-22
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-07-25
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-07-25
OWI Bone Fixation Cerclage, Sublaminar Orthopedic Class 2 888.3010 2026-01-30
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-06-22
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-06-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-06-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-06-22
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-01-30
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-06-22
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-06-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-06-22

Official Correspondent

Heidi Funston

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Avalign Technologies
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
8010372 Instrumed GmbH dba Avalign German Specialty Instruments TUTTLINGEN Baden-Wurttemberg, DE
1421101 Instrumed International Inc dba Avalign German Specialty Instruments SCHAUMBURG, IL, US
3004215117 MILLENNIUM SURGICAL CORP Schaumburg, IL, US
3008864603 AVALIGN TECHNOLOGIES, Inc. Fort Wayne, IN, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
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
K141398 Medicrea International SA PASS LP SPINAL SYSTEM 2015-01-09
K160980 Spineology, Inc. Threshold Pedicular Fixation System, Palisade Pedicular Fixation System 2016-05-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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).
Z-0004-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.
Z-0021-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1527105. Last updated year: 2026. Please use registration number 1527105 when referencing this establishment in official correspondence.
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