RUDISCHHAUSER SURGICAL INSTRUMENTS MANUFACTURING GMBH

FDA Device Registration & Listing · TUTTLINGEN Baden-Wurttemberg, DE · Registration 8010300

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
8010300
FEI Number
3008237805
Entity Name
RUDISCHHAUSER SURGICAL INSTRUMENTS MANUFACTURING GMBH
City/State/Country
TUTTLINGEN Baden-Wurttemberg, DE
Establishment Address
GAENSAECKER 28, TUTTLINGEN Baden-Wurttemberg 78532, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
RUDISCHHAUSER SURGICAL INSTRUMENTS MANUFACTURING GMBH (Owner Number: 8010300)
Owner / Operator Contact Address
GAENSAECKER 28, --, TUTTLINGEN, DE-BW 78532, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

77111875 IN1539

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GAD Retractor General, Plastic Surgery Class 1 878.4800 1984-09-07
HWA Impactor Orthopedic Class 1 888.4540 2013-03-16
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2013-09-05
HBG Drills, Burrs, Trephines & Accessories (Manual) Neurology Class 2 882.4300 2014-02-17
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-09-05
KBX Screw, Tonsil Ear, Nose, Throat Class 1 874.4420 2013-09-05
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2008-01-26
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2013-01-30
HTF Curette General, Plastic Surgery Class 1 878.4800 2018-09-10
GDJ Clamp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2014-07-15
KBM Dissector, Tonsil Ear, Nose, Throat Class 1 874.4420 2013-09-05
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2019-03-26
HXX Screwdriver Orthopedic Class 1 888.4540 2014-01-28
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2013-01-29
EMM Chisel, Osteotome, Surgical Dental Class 1 872.4565 1984-02-29
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2015-04-28

Official Correspondent

Marlene Deiner

US Agent Details

Angelika Scherp Business: BUSINESS SUPPORT INTERNATIONAL Email: info@bsi-fda.com Phone: (212) 3318358

Related Public Records

Same Entity

RUDISCHHAUSER SURGICAL INSTRUMENTS MANUFACTURING 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
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
K851170 The Huxley Instrument Corp. DISSECTING TWEEZER #283-72PCS. SS 410 1985-04-25
K821248 Conphar, Inc. ROCHESTER PEAN FORCEPS 1982-05-28

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-0010-2008 N/A 1
EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
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.

Similar Registrations

Registration Number Establishment Name Location
3011050528 FREEHOLD SURGICAL, INC. New Hope, PA, US
3021006167 KIMS MED CO., LTD. Gwangju, KR
3045009502 WISDOM MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD Shanghai, CN
3032847175 BIOPHYX SURGICAL, INC. Edgewater, MD, US
9681129 BEMA-GMBH & CO. KG EMMINGEN Baden-Wurttemberg, DE
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010300. Last updated year: 2026. Please use registration number 8010300 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.