Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611827

FEI Number

3002807421

Entity Name

ERCHINGER AG

City/State/Country

TUTTLINGEN Baden-Wurttemberg, DE

Establishment Address

Rudolf-Diesel Strasse 20, TUTTLINGEN Baden-Wurttemberg 78532, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ERCHINGER AG (Owner Number: 8010475)

Owner / Operator Contact Address

RUDOLF-DIESEL-STRASSE 20, TUTTLINGEN, DE-BW D-78532, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Distraction Instrument Drill Sleeve Polyaxial (2.5mm) Compression Instrument T2 ICF System RECTAL SPECULAE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-07-03
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2010-02-10
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	1999-06-17
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2013-02-25
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2010-02-09
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2010-02-09
KIL	Positioner, Socket	Orthopedic	Class 1	888.4540	2010-02-10
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2010-02-08
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-03-25
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2010-04-08
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2010-02-08
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2025-03-25
FBX	Sound, Urethral, Metal Or Plastic	Gastroenterology, Urology	Class 1	876.5520	2014-01-09
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2025-06-16
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2010-02-09
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-07-01
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-01-31
HXW	Bender	Orthopedic	Class 1	888.4540	2010-02-09
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2010-02-08
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2025-06-16
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2010-02-22
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-04-29
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2010-02-09
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2017-07-25
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1999-05-07
HTQ	Broach	Orthopedic	Class 1	888.4540	2010-02-09
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-03-25
HCD	Cannula, Ventricular	Neurology	Class 1	882.4060	2015-12-17
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2010-02-09
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2025-03-25
FGN	Retractor, Non-Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	1999-06-17
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2010-02-10
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	1998-07-02
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2010-02-08
KAL	Retractor, Ent	Ear, Nose, Throat	Class 1	874.4420	2025-03-25
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	1999-06-17
KTZ	Caliper	Orthopedic	Class 1	888.4150	2010-02-10
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2010-02-09
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2025-03-25
KAK	Probe, Ent	Ear, Nose, Throat	Class 1	874.4420	1999-06-17
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2010-02-09
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1998-07-20
HXB	Probe	Orthopedic	Class 1	888.4540	2010-02-09
HWB	Extractor	Orthopedic	Class 1	888.4540	2010-02-10
GEC	Brush, Scrub, Operating-Room	General, Plastic Surgery	Class 1	878.4800	2013-01-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-06-16
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-04-29
QWK	Prosthesis, Posterior Spinal Elements	Unknown	Class 3	N/A	2025-04-29
FDG	Retractor, Fiberoptic	Gastroenterology, Urology	Class 1	876.4530	1999-05-07
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1999-06-17
HWT	Template	Orthopedic	Class 1	888.4800	2010-02-10
KTE	Trocar, Ent	Ear, Nose, Throat	Class 1	874.4420	1999-05-07
HHM	Sound, Uterine	Obstetrics/Gynecology	Class 1	884.4530	1999-06-17
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-04-29
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-04-29
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-04-29
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	2017-07-25
HTX	Rongeur	Orthopedic	Class 1	888.4540	2010-02-09
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2010-02-08
GAH	Stylet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2025-03-25
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	Class 2	876.4400	2008-11-06
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2010-02-08
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-04-29
FFQ	Speculum, Rectal	Gastroenterology, Urology	Class 1	876.4730	1999-05-07
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2010-02-10
EQH	Source, Carrier, Fiberoptic Light	Ear, Nose, Throat	Class 1	874.4350	2010-03-08
HXC	Wrench	Orthopedic	Class 1	888.4540	2010-02-10
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	1999-04-01
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1999-06-17
HXO	Pusher, Socket	Orthopedic	Class 1	888.4540	2010-02-09

Official Correspondent

No official correspondent registered.

US Agent Details

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

Related Public Records

Same Entity

ERCHINGER AG

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
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
K141398	Medicrea International SA	PASS LP SPINAL SYSTEM	2015-01-09
K160980	Spineology, Inc.	Threshold Pedicular Fixation System, Palisade Pedicular Fixation System	2016-05-26

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 9611827. Last updated year: 2026. Please use registration number 9611827 when referencing this establishment in official correspondence.