Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614986

FEI Number

3003424264

Entity Name

OTTO LEIBINGER GMBH

City/State/Country

MUEHLHEIM Baden-Wurttemberg, DE

Establishment Address

27 GRIESWEG, MUEHLHEIM Baden-Wurttemberg 78570, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

OTTO LEIBINGER GMBH (Owner Number: 9032125)

Owner / Operator Contact Address

27 GRIESWEG, --, MUHLHEIM, DE-NOTA 78570, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Miller Bone File Bone File BAND PUSHER Miller Bone File Bone File TAMP (MULTIPLE BRANDS) Sharp Hook PLASTIC SURGERY (MULTIPLE BRADS) Sharp Hook GSP24 Prichard Periotome Buser Molt Goldman Fox Seldin Raspatorie Periostal Elevator Gauze Packer Bone Scraper Scalpel Handle Guide Drill Periodontal Probe Retractors all types Minnesota Retractor Mosquito Forceps Ball Spike Fragment Reduction Tool Ergo Clip Wash Tray Orthodontic Plier Mathieu Needle Holder Needle Holder, dental Micro Needle Holder GUIDES (MULTIPLE BRANDS) Paralell Drilling Guide Double Drill Sleeve Ball Spike Bone File Castroveijo Measuring Gauge Measuring Gauge Bone Mill Soft Corn Knife Golf Stick Knife Excavator Tissue Pliers Tooth Tweezers Micro Tweezers Suture Tweezers Tooth Forceps Root Splinter Forceps Adson Tweezers Dressing Forceps MOSQUITO FORCEPS DOUBLE SIDED BAND SETTE Dollar Dissector Filter for Suction Tube Suction Tube with filter Soft Corn Knife Golf Stick Knife Mirror Handle Bone Curette Curette McGlamry Bullneck Curette Ivory Rubber Dam Punch Chisel Root Elevator BAll Spike Beebee Crown Scissors Oringer Retractor RETRACTOR Woodson Dural Separator PERIODONTIC (MULTIPLE BRANDS) Dental Scaler

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEO	File, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-02-05
ECS	Pusher, Band, Orthodontic	Dental	Class 1	872.4565	1998-02-02
EMI	File, Bone, Surgical	Dental	Class 1	872.4565	2003-01-31
HXG	Tamp	Orthopedic	Class 1	888.4540	2002-05-24
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2022-02-21
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2001-08-26
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2008-02-18
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2008-02-18
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2023-06-05
HXY	Brace, Drill	Orthopedic	Class 1	888.4540	2013-02-27
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2012-06-18
EIG	Retractor, All Types	Dental	Class 1	872.4565	2008-02-18
EMD	Hemostat, Surgical	Dental	Class 1	872.4565	2023-06-05
HXB	Probe	Orthopedic	Class 1	888.4540	2016-12-12
HTX	Rongeur	Orthopedic	Class 1	888.4540	2014-05-26
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2008-02-18
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2026-05-11
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2012-06-18
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2002-03-06
HTP	File	Orthopedic	Class 1	888.4540	2016-12-12
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2008-02-21
LYS	Bone Mill	Orthopedic	Class 1	888.4540	2008-02-18
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2002-08-06
EKC	Excavator, Dental, Operative	Dental	Class 1	872.4565	2012-06-18
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	1998-02-02
ECR	Setter, Band, Orthodontic	Dental	Class 1	872.4565	1998-02-02
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-09-17
KCB	Tube, Tonsil Suction	Ear, Nose, Throat	Class 1	874.4420	2008-02-18
GDN	Knife, Amputation	General, Plastic Surgery	Class 1	878.4800	2013-02-05
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2023-06-05
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2003-05-27
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2008-02-21
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2006-02-28
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2008-02-18
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2013-02-27
EIR	Scissors, Collar And Crown	Dental	Class 1	872.4565	2012-06-18
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2001-08-13
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2001-08-13

Official Correspondent

TINA LEIBINGER-TOTH

US Agent Details

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

Related Public Records

Same Entity

OTTO LEIBINGER 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
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

Registration Number	Establishment Name	Location
9611102	RICHARD WOLF GMBH	KNITTLINGEN Baden-Wurttemberg, DE
8040278	Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, PK
3008338766	CROWN SURGICAL CORP.	Sialkot Punjab, PK
3010041511	Teleflex LLC (NADC)	Olive Branch, MS, US
3032747418	HEXAMED PVT LTD	Sialkot Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614986. Last updated year: 2026. Please use registration number 9614986 when referencing this establishment in official correspondence.