FMI MEDISCH BV

FDA Device Registration & Listing · Schiedam Zuid-Holland, NL · Registration 3010370500

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
3010370500
FEI Number
3010370500
Entity Name
FMI MEDISCH BV
City/State/Country
Schiedam Zuid-Holland, NL
Establishment Address
De Brauwweg 17, Schiedam Zuid-Holland 3125 AE, NL
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
FMI Medisch BV (Owner Number: 10043390)
Owner / Operator Contact Address
De Brauwweg 17, Schiedam, NL-ZH 3125 AE, NL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Vanguard PFR PEDICLE PROBE WITH BALL TIP MULTI-AXIAL SCREWDRIVER CANNULATED SCREWDRIVER T20 RATCHET SCREWDRIVER UNIVERSAL PEDICLE SCREWDRIVER ST MULTI AXIAL TRANSVERSE CONNECTOR ST ILIAC ROD LEFT SIDE ST ILIAC ROD RIGHT SIDE Prodisc C Nova; Prodisc C SK; Prodisc C Vivo Synplug Cervical Spine Truss System (CSTS) Vanguard PFR 7mm TAP 5mm TAP 12mm stop tap 6mm TAP Ø5mm CANNULATED TAP Ø7mm CANNULATED TAP Ø6mm CANNULATED TAP Cervical Spine Truss System (CSTS) Interbody Fusion Device INDEX RING FOR SETSCREW HOLDER CLIP INTRODUCER Pins for distractor/compressor Distractor / compressor Snap-on handle for drills Screw aligner VERTICALE WINX Blade Setscrew holder Vanguard PFR T30 SHAFT ROD GRIPPER U.L.I.S.™ UNIVERSAL SCREWDRIVER LUMIS UNIVERSAL SCREWDRIVER AXIAL ROD INTRODUCER / CLIP GUIDE - U1 - A337 New Fixed Angle Drill Guide Vanguard PFR AXIAL ROD INTRODUCER / CLIP GUIDE - U1 - A337N1 LONG SCREW FOR ROD PERSUADER Setscrew guide + Counter torque COUNTER TORQUE SCREW FOR ROD PERSUADER ROD PERSUADER Vanguard PFR Vanguard PFR Hexanium® TLIF Screw extender ENLARGED SCREW EXTENDER Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device

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 2017-04-21
GAD Retractor General, Plastic Surgery Class 1 878.4800 2013-02-12
PGM Growing Rod System Orthopedic Class 2 888.3070 2026-01-27
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2020-01-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-05-11
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2013-02-12
HXD Clamp General, Plastic Surgery Class 1 878.4800 2013-02-12
HXW Bender Orthopedic Class 1 888.4540 2013-02-12
HXB Probe Orthopedic Class 1 888.4540 2013-03-19
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2020-05-26
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2021-09-21
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-09-21
HXX Screwdriver Orthopedic Class 1 888.4540 2013-03-19
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-03-19
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-03-19
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-03-19
QLQ Manual Instruments Designed For Use With Total Disc Replacement Devices Orthopedic Class 2 888.4515 2023-12-01
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2020-01-16
LZN Cement Obturator General, Plastic Surgery Class 2 878.3300 2013-02-12
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2023-11-22
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2023-11-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-12-31
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2026-02-10
HWB Extractor Orthopedic Class 1 888.4540 2013-02-12
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-02-12
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-02-12
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-02-12
HWX Tap, Bone Orthopedic Class 1 888.4540 2013-02-12
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2017-04-21
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2020-12-31
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2013-02-12
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2013-02-12
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-02-12
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-02-12
HTW Bit, Drill Orthopedic Class 1 888.4540 2013-02-12
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-07-18
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-07-18
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2016-12-19
OTJ Laparoscopic Single Port Access Device Gastroenterology, Urology Class 2 876.1500 2016-12-19
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2014-08-27
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-08-27
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2014-08-27
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-08-27
HWR Driver, Prosthesis Orthopedic Class 1 888.4540 2013-02-12
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2020-01-16
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2013-02-12
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 2013-03-19
HXY Brace, Drill Orthopedic Class 1 888.4540 2013-02-12
KTZ Caliper Orthopedic Class 1 888.4150 2013-02-12
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2017-04-21
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-04-21
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2017-04-24
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-04-12
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-03-19
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-03-19
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-03-19
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-03-19
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-03-19
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2019-11-15

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

FMI Medisch BV
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-0031-2014 Aesculap, Inc. 1
UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0034-2022 Flower Orthopedics Corporation 2
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0013-05 Biomet, Inc. 2
Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.
Z-0026-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Z-0027-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010370500. Last updated year: 2026. Please use registration number 3010370500 when referencing this establishment in official correspondence.
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