FRIEDRICH DANIELS GMBH

FDA Device Registration & Listing · SOLINGEN North Rhine-Westphalia, DE · Registration 9611390

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
9611390
FEI Number
3002806773
Entity Name
FRIEDRICH DANIELS GMBH
City/State/Country
SOLINGEN North Rhine-Westphalia, DE
Establishment Address
DOENHOFFSTRASSE 6, SOLINGEN North Rhine-Westphalia 42655, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
FRIEDRICH DANIELS GMBH (Owner Number: 8010164)
Owner / Operator Contact Address
DOENHOFFSTRASSE 6, --, SOLINGEN, DE-NOTA 42655, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

integra X-Spine SPIRA Open Matrix ALIF and LLIF SCREW HOLDING FORCEPS 45DEG Tibial Awl Malibu Balanced Knee System SPIRA-C Open Matrix Cervical Interbody Anatomical Shoulder TM Combined System Integra Integra PACIFICA RETRACTOR NGK Femoral Instruments Hollywood

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HXW Bender Orthopedic Class 1 888.4540 2015-03-26
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 1992-10-22
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2014-08-18
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2021-04-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-04-14
HWT Template Orthopedic Class 1 888.4800 2021-03-12
HWJ Awl Orthopedic Class 1 888.4540 2019-03-22
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2015-05-18
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-01-12
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-12
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-01-12
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Orthopedic Class 2 888.3170 2025-01-12
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-12
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-22
HTD Forceps General, Plastic Surgery Class 1 878.4800 1992-10-28
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-22
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-22
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-01-29
MNI Orthosis, Spinal Pedicle 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
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 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
GAC Rasp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2000-05-04
HWP Punch, Femoral Neck Orthopedic Class 1 888.4540 2001-05-03
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2025-01-22
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-22
FST Light, Surgical, Fiberoptic General, Plastic Surgery Class 2 878.4580 2025-01-13
EMH Forceps, Rongeur, Surgical Dental Class 1 872.4565 1997-07-01
PEK Spinous Process Plate Orthopedic Class 2 888.3050 2018-12-20
HTO Reamer Orthopedic Class 1 888.4540 1992-10-17
GFJ Mallet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2003-10-21
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2025-01-22
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-22
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-01-22
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2010-07-06
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 1992-10-20
GDR Saw, Manual And Accessories General, Plastic Surgery Class 1 878.4800 2001-08-05
HWN Instrument, Compression Orthopedic Class 1 888.4540 2014-10-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-12-20
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2018-12-20
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2018-12-20
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2021-04-14
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2018-06-21
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2018-06-21
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2018-06-21
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2000-05-04
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-13
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2022-09-12
FMF Syringe, Piston General Hospital Class 2 880.5860 2022-09-12
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2016-12-15
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-12-15
HXX Screwdriver Orthopedic Class 1 888.4540 2015-03-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-29
HXD Clamp General, Plastic Surgery Class 1 878.4800 2015-03-26
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2016-12-15
GAD Retractor General, Plastic Surgery Class 1 878.4800 1992-10-17
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2022-03-08
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2022-03-08
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-13
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2013-07-25
HTX Rongeur Orthopedic Class 1 888.4540 2002-06-01
HWO Skid, Bone Orthopedic Class 1 888.4540 1992-10-17
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-29
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 1997-10-15
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-13
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-13
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-13
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-01-13
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-01-13
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-13
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2025-01-22
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-22
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-22
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2025-01-22
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2025-01-22
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2025-01-22
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2018-12-20
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2018-12-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2018-12-20
GEG Elevator, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1992-10-17

Official Correspondent

BERND DANIELS

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

FRIEDRICH DANIELS GMBH
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
K192492 Astura Medical, LLC EL CAPITAN Anterior Lumber Interbody System 2020-04-21
K212498 Nexus Spine, LLC Stable-L Standalone Lumbar Interbody System 2022-03-18
K142269 Reliance Medical Systems, LLC Reliance Cervical IBF System 2015-06-09
K122085 Omni Surgical, LP Dba Spine360 STINGRAY CERVICAL CAGE 2012-10-17
K120275 Synthes (Usa), LLC SYNTHES ACIS/VERTEBRAL SPACER CR 2012-05-25

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-0005-2023 Wright Medical Technology, Inc. 2
stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611390. Last updated year: 2026. Please use registration number 9611390 when referencing this establishment in official correspondence.
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