Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033536255

FEI Number

3033536255

Entity Name

DHF PRAEZISIONSMECHANIK GMBH

City/State/Country

Tuntenhausen Bavaria, DE

Establishment Address

Oberrainer Feld 41, Tuntenhausen Bavaria 83104, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

DHF Praezisionsmechanik GmbH (Owner Number: 10091494)

Owner / Operator Contact Address

Oberrainer Feld 41, Tuntenhausen, DE-BY 83104, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HIP7 52411A PATIENT REFERENCE ARRAY Y-GEOMETRY X-PRESS 52410A PATIENT REFERENCE ARRAY T-GEOMETRY X-PRESS 55104 INSTRUMENT ADAPTER CLAMP STARLINK SIZE XL 55101 INSTRUMENT ADAPTER CLAMP STARLINK SIZE S 52429 BONE FIXATOR 2-PIN X-PRESS 55102 INSTRUMENT ADAPTER CLAMP STARLINK SIZE M 41798 INSTRUMENT TRACKING ARRAY STARLINK SIZE M 41802 INSTRUMENT TRACKING ARRAY STARLINK SIZE XL 55013 INSTRUMENT ADAPTER STARLINK ANGLED 45° 55103 INSTRUMENT ADAPTER CLAMP STARLINK SIZE L 41799 INSTRUMENT TRACKING ARRAY STARLINK SIZE ML 41801 INSTRUMENT TRACKING ARRAY STARLINK SIZE L 55016 INSTRUMENT ADAPTER STARLINK EXTENSION 50 MM 55830-29 INSTRUMENT TRACKING ARRAY S&T (SIZE L) 19142-06 RADIOLUCENT DRAPELINK INTERFACE FOR CALIBRATION PHANTOM INTRAOPERATIVE CT 41767-19A MICROSCOPE TRACKING ARRAY 41767-55B MICROSCOPE ADAPTER FOR TRACKING ARRAY (ZEISS) 52424 DOUBLE OPEN-END WRENCH (10 X 14 MM) 55103 INSTRUMENT ADAPTER CLAMP STARLINK SIZE L 55013 INSTRUMENT ADAPTER STARLINK ANGLED 45° 41799 INSTRUMENT TRACKING ARRAY STARLINK SIZE ML 41860-35C ULTRASOUND NAVIGATION ADAPTER (BK 8862/8863/N11C5S) 52122A Skull Reference Array 55791A HANDLE FOR MULTIPLE TIP POINTER 41860-40A ULTRASOUND NAVIGATION ADAPTER (BK N13C5) 55101 INSTRUMENT ADAPTER CLAMP STARLINK SIZE S 41802 INSTRUMENT TRACKING ARRAY STARLINK SIZE XL 55104 INSTRUMENT ADAPTER CLAMP STARLINK SIZE XL 52129B Skull Reference Base 41798 INSTRUMENT TRACKING ARRAY STARLINK SIZE M 55102 INSTRUMENT ADAPTER CLAMP STARLINK SIZE M 19142-06 RADIOLUCENT DRAPELINK INTERFACE FOR CALIBRATION PHANTOM INTRAOPERATIVE CT 41860-35B ULTRASOUND NAVIGATION ADAPTER (BK 8862/8863/N11C5S) 41860-43 ULTRASOUND NAVIGATION ADAPTER (BK X18L5S) 41801 INSTRUMENT TRACKING ARRAY STARLINK SIZE L 55105 INSTRUMENT ADAPTER CLAMP STARLINK FOR RECTANGULAR INSTRUMENTS 55950-70G VARIOGUIDE HARDWARE (VERSION G) 55950-40B VARIOGUIDE ARRAY 41734 Pat. Ref. Attachment for Skull Clamp 41725 Pat. Ref. Array for Skull Clamp 41860-40 ULTRASOUND NAVIGATION ADAPTER (BK N13C5) 56302 Cirq Robotic Tracking Array Spine 10 56302A CIRQ ROBOTIC TRACKING ARRAY 10 51839-03 Drill Guide Array 51839-32 Drill Guide Tube (3.2 mm) 51839-01 Drill Guide Depth Control ( 0-60 mm) 51839-93 Drill Guide Trocar Insert 2 mm 51839-26 Drill Guide Tube (2.6 mm) 51839-96 Drill Guide Trocar Insert 3.2 mm 51839-20 Drill Guide Tube (2 mm) 51839-95 Drill Guide Trocar Insert 2.6 mm 51839-24 Drill Guide Tube (2.4 mm) 51839-94 Drill Guide Trocar Insert 2.4 mm 51839-97 Drill Guide Trocar Insert 4.5 mm 51839-02 Drill Guide Depth Control (60-100 mm) 51839-45 Drill Guide Tube (4.5 mm) 51839 Drill Guide Handle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-10-09
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-01-28
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-01-28
GXL	Screwdriver, Skullplate	Neurology	Class 1	882.4900	2025-01-28
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-01-28
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-01-28
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-01-28

Official Correspondent

Bernhard Fischbacher

US Agent Details

Rhonda Alexander Business: IUVO Consulting, LLC Email: ralexander@iuvoconsulting.com Phone: (757) 5824337

Related Public Records

Same Entity

DHF Praezisionsmechanik 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
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26
K010427	Walter Lorenz Surgical, Inc.	LORENZ FIDUCAIL SCREW	2001-03-15
K812744	Progress Mankind Technology	LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER	1981-12-03
K092467	Brainlab AG	VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED	2010-05-06
K031454	Biomet, Inc.	ACUMEN SURGICAL NAVIGATION SYSTEM	2004-07-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0001-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0002-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0005-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System, eNlite System with Dell laptop computer model D800, Stryker # 7700-300-000.
Z-0006-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System Remote Planning Stations with Dell laptop computer model D800, Stryker # 7700-010-000 and 6000-300-000.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033536255. Last updated year: 2026. Please use registration number 3033536255 when referencing this establishment in official correspondence.