RISA GmbH

FDA Device Registration & Listing · Engen Baden-Wurttemberg, DE · Registration 3007222353

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
3007222353
FEI Number
3007222353
Entity Name
RISA GmbH
City/State/Country
Engen Baden-Wurttemberg, DE
Establishment Address
Industriestrasse 7, Engen Baden-Wurttemberg 78229, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device
Owner / Operator
RISA GmbH (Owner Number: 10027032)
Owner / Operator Contact Address
Industriestrasse 7, Engen, DE-BW 78229, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Drill saw blade risa Reamer

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HXX Screwdriver Orthopedic Class 1 888.4540 2023-02-14
HTW Bit, Drill Orthopedic Class 1 888.4540 2008-09-22
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2025-07-23
HTO Reamer Orthopedic Class 1 888.4540 2025-04-24

Official Correspondent

Peter Voigtsberger

US Agent Details

David Lennarz Business: Registrar Corp. Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

RISA 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
K953012 Boston Surgical Products, Inc. DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS 1995-07-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0021-2015 Biomet, Inc. 1
Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007222353. Last updated year: 2026. Please use registration number 3007222353 when referencing this establishment in official correspondence.
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