3D SYSTEMS - LAYERWISE

FDA Device Registration & Listing · Heverlee Vlaams Brabant, BE · Registration 3010705004

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
3010705004
FEI Number
3010705004
Entity Name
3D SYSTEMS - LAYERWISE
City/State/Country
Heverlee Vlaams Brabant, BE
Establishment Address
Grauwmeer 14, Heverlee Vlaams Brabant 3001, BE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
LayerWise nv (Owner Number: 10048431)
Owner / Operator Contact Address
5381 South Alkire Circle, Littleton, CO 80127, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Cervical Spacer

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-08-16
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2023-11-10
PLR Spinal Vertebral Body Replacement Device - Cervical Orthopedic Class 2 888.3060 2023-11-10
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-03-24
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2017-03-24
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-04-08
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-07-24
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-07-24
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2022-10-28
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2015-01-13
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2022-10-28
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-03-24
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2017-03-24
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-07-25
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2017-07-25
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-06-28
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2026-04-08
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-08-16
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2024-08-16
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2024-08-16
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-08-16
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-04-08
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2026-04-08
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-04-08
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2022-10-28
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2022-10-28
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2022-10-28
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2022-10-28
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2024-08-16
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-03-24
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-03-24
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-08-07
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2017-08-07
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-08-16
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2024-08-16

Official Correspondent

Archana Gopalan

US Agent Details

Archana Gopalan Business: 3D Systems, Inc. Email: Archana.Gopalan@3DSystems.com Phone: (720) 6431001

Related Public Records

Same Entity

LayerWise nv
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
K223430 Life Spine, Inc. ProLift Micro Expandable Spacer System 2023-05-04
K102293 Globus Medical, Inc. CALIBER SPACER 2011-01-05
K193541 Nu Vasive, Incorporated NuVasive Cohere Thoracolumbar Interbody System 2020-03-30
K080401 Advanced Medical Technologies AG SHELL CAGE, WAVE CAGE, LOOP CAGE 2008-05-09
K200084 Zavation Medical Products, LLC Zavation IBF System 2020-10-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0010-2020 Implant Direct Sybron Manufacturing, LLC 2
ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026 S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil 2
IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020 Implant Direct Sybron Manufacturing, LLC 2
ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 2
Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
Z-0029-05 Implant Innovations, Inc. 2
EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010705004. Last updated year: 2026. Please use registration number 3010705004 when referencing this establishment in official correspondence.
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