C&W SWISS, INC.

FDA Device Registration & Listing · CLAYTON, OH, US · Registration 3004635447

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
3004635447
FEI Number
3004635447
Entity Name
C&W SWISS, INC.
City/State/Country
CLAYTON, OH, US
Establishment Address
100 LAU PKWY, CLAYTON, OH 45315, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
C&W SWISS, INC. (Owner Number: 9063235)
Owner / Operator Contact Address
100 Lau Parkway, --, Clayton, OH 45315, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Spreader Pin A, Spreader Pin B, Spreader Pin C, Spreader Pin D Pin to Rod Clamp Fastener, Foot Plate Bolt, Calcaneus Pin Hook Fastener, Calcaneus Pin Hook TM Ankle Angle Locking Pin, Rail Hole Stabilizer ZIMMER TRABECULAR METAL TOTAL ANKLE Pyrenees, Blue Ridge Range, Mesa, Denali, Natural Bridge Aleutian Range, Ari Cayman Buttress Everest PLATE, FIXATION, BONE, SCREW, FIXATION, BONE Range Small Stature, Mesa Caspian, Mesa mini, Denali mini PRESIDIO CoCr Wire, Nile Santorini Pyrenees Chesapeake Cervical

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 2013-01-28
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-28
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-28
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-28
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-28
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-11-07
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-28
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2022-01-27
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-01-27
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2022-01-27
HXX Screwdriver Orthopedic Class 1 888.4540 2013-02-12
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2013-01-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-28
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-28
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-28
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-28
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-28
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2016-03-30
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2016-12-07
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-12-07
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-12-07
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2016-12-07
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2016-12-07
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2022-01-27
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2022-01-27
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-01-27
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2022-01-27
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-01-27
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2022-01-27
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2022-01-27
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-01-27
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2022-01-27
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2022-01-27
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2022-01-27
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2022-01-27
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2022-01-27
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2022-01-27
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-28
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2016-03-14
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2016-03-14
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2025-05-27
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2022-01-27
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-01-27
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2022-01-27
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2022-01-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-12-18
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2022-01-27
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2022-01-27
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-28
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2013-01-28
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-28
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-28
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-28
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-28
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2016-12-07
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2016-12-07
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2016-12-07
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2022-01-27
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-28
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-28
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-28
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-28
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-28
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-23
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2013-01-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-01-23
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2022-01-27
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-28
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2016-03-30
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-03-30
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-03-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-12-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-12-18
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-02-06
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-02-06
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-23
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2023-01-12
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2023-01-12
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2016-12-07
HXX Screwdriver Orthopedic Class 1 888.4540 2013-02-12
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-28
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2022-01-27
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-12-05
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2022-01-27
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2022-01-27
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-01-27
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2013-01-23
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2013-01-23
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2022-01-27
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-01-27
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2022-01-27
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2022-01-27
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2022-01-27
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-28
HWT Template Orthopedic Class 1 888.4800 2013-01-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-28
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-28
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-28
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-28
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-01-29
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2014-01-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2014-01-29
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-01-29
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2014-01-29
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2014-01-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-02-28
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-28
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-28
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-28
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-28
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-28
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-03-30
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2016-03-30
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-03-30
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2016-03-30
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2013-01-28
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-01-29
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-28
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-28
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-28
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-28
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-01-29
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2013-01-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2023-01-12
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2023-01-12
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-01-12

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

C&W SWISS, INC.
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
K032604 Co-Ligne AG GII SPINAL FIXATION SYSTEM 2004-01-20
K964304 Osteonics Corp. OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY 1997-01-17
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-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 3004635447. Last updated year: 2026. Please use registration number 3004635447 when referencing this establishment in official correspondence.
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