Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615013

FEI Number

3002560459

Entity Name

Schilling CNC-Technik GmbH

City/State/Country

MUHLHEIM-STETTEN Baden-Wurttemberg, DE

Establishment Address

JOSEF-LANG-STR. 30 A, MUHLHEIM-STETTEN Baden-Wurttemberg D-78570, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Schilling CNC-Technik GmbH (Owner Number: 9033807)

Owner / Operator Contact Address

JOSEF-LANG-STR. 30 A, --, MUHLHEIM-STETTEN, DE-BW D-78570, 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
IQG	Adaptor, Holder, Syringe	Physical Medicine	Class 1	890.5050	1999-08-16
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2021-02-24
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	1999-08-16
HXX	Screwdriver	Orthopedic	Class 1	888.4540	1999-07-29

Official Correspondent

Dennis SCHILLING

US Agent Details

Beate Weiss-Krull Business: Beate Weiss-Krull, Attorney at Law Email: bea@weisskrull-law.com Phone: (503) 2340355

Related Public Records

Same Entity

Schilling CNC-Technik GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615013. Last updated year: 2026. Please use registration number 9615013 when referencing this establishment in official correspondence.