Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611813

FEI Number

3002806685

Entity Name

CHRISTIAN DIENER GMBH

City/State/Country

TUTTLINGEN Baden-Wurttemberg, DE

Establishment Address

RUDOLF-DIESEL-STR. 18, TUTTLINGEN Baden-Wurttemberg 78532, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

CHRISTIAN DIENER GMBH (Owner Number: 8010268)

Owner / Operator Contact Address

RUDOLF-DIESEL-STR. 18, --, TUTTLINGEN, DE-NOTA 78532, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1999-05-05
HXS	Twister, Wire	Orthopedic	Class 1	888.4540	1984-03-01
MCM	Implant, Cochlear	Unknown	Class 3	N/A	2017-07-12
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2020-10-12
HWJ	Awl	Orthopedic	Class 1	888.4540	2023-09-06
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2017-12-04
HTX	Rongeur	Orthopedic	Class 1	888.4540	1999-05-05
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2017-12-04
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-01-28
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-01-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-01-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-01-28
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-01-28
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2018-12-17
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2018-12-17
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2018-12-17
HXG	Tamp	Orthopedic	Class 1	888.4540	2023-08-21
PLR	Spinal Vertebral Body Replacement Device - Cervical	Orthopedic	Class 2	888.3060	2021-01-07
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2021-01-07
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	1996-07-05
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2016-11-30
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2020-09-25
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2021-01-07
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2021-01-07
MJO	Prosthesis, Intervertebral Disc	Unknown	Class 3	N/A	2016-03-21
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-01-28
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2013-02-26
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-01-28
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2021-01-07
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-01-28
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2021-01-07
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-02-26
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2021-01-07
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-01-28
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-01-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-01-28
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2025-01-28
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2025-01-28
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2021-01-07
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2017-12-04
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2017-12-04
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2017-12-04
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2023-12-21
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	1984-02-07
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	1996-07-05
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2025-01-28
EGN	Scissors, Surgical Tissue, Dental	Dental	Class 1	872.4565	1984-02-07
NQW	Orthosis, Spine, Plate, Laminoplasty, Metal	Orthopedic	Class 2	888.3050	2021-01-07
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	1996-07-05
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2021-01-07
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2021-01-07
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2021-01-07
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2021-01-07
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-01-28
HWT	Template	Orthopedic	Class 1	888.4800	2023-08-21
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2024-04-25
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2017-12-04
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	1996-07-05
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-01-28

Official Correspondent

Franz Bentlage

US Agent Details

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

Related Public Records

Same Entity

CHRISTIAN DIENER 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
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-0003-2012	Cochlear Americas Inc.	3	Cochlear Nucleus CI512 Cochlear Implant, REF Z209051, New with Nucleus 5, Sterile EO, Made in Australia, Cochlear Ltd 14 Mars Road, Lane Cove 2066, Australia. The cochlear implant is intended to restore a level of auditory sensation via the electrical stimulation of the auditory nerve.
Z-0044-05	Advanced Bionics	3	Advanced Bionics implantable cochlear stimulator CLARION 1.2 Models AB-5100L AB-5100R AB-5100ML/R (For Export Only) AB-5100H AB-5100H-01A
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
Z-0028-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L

Similar Registrations

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9610622	STRYKER TRAUMA GMBH	SCHOENKIRCHEN Schleswig-Holstein, DE
3036795921	KLS MARTIN SE & CO. KG	Fridingen Baden-Wurttemberg, DE
1020279	SMITH & NEPHEW, INC.	MEMPHIS, TN, US
3004215117	MILLENNIUM SURGICAL CORP	Schaumburg, IL, US
3012755988	Ortho Solutions Sdn Bhd	Prai, Penang Pulau Pinang, MY

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611813. Last updated year: 2026. Please use registration number 9611813 when referencing this establishment in official correspondence.