ARTHREX GMBH

FDA Device Registration & Listing · Odelzhausen Bavaria, DE · Registration 3007193505

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
3007193505
FEI Number
3007193505
Entity Name
ARTHREX GMBH
City/State/Country
Odelzhausen Bavaria, DE
Establishment Address
Oskar-von-Miller Strasse 6, Odelzhausen Bavaria 85235, DE
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
ARTHREX, INC. (Owner Number: 1220287)
Owner / Operator Contact Address
1370 CREEKSIDE BLVD., --, Naples, FL 34108, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

SHAVER BLADES drill bit Instrument, manual, surgical, general use ORTHOPEDIC MANUAL INSTRUMENTS VARIOUS BURS DOUBLE SYRINGE (ACP) SYSTEM CAMERA, CINE, ENDOSCOPIC, WITHOUT AUDIO INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT orthopedic manual instrument

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use Clinical Chemistry Class 1 862.2050 2017-01-24
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2007-08-23
HTW Bit, Drill Orthopedic Class 1 888.4540 2007-08-23
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2018-06-26
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2018-06-26
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2007-08-23
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2007-08-23
GFF Bur, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4820 2007-08-23
FMF Syringe, Piston General Hospital Class 2 880.5860 2009-04-16
FWL Camera, Cine, Endoscopic, Without Audio General, Plastic Surgery Class 1 878.4160 1994-01-27
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 1996-08-07
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2001-07-13

Official Correspondent

Barry Dietz

US Agent Details

Barry Dietz Business: Arthrex Inc Email: Regulatory_Affairs@Arthrex.com Phone: (800) 9337001

Related Public Records

Same Entity

ARTHREX, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3031238646 Arthrex Medical Device (Shanghai) Co. Ltd. Shanghai, CN
3013700547 Arthrex Korea Ltd. Gangnam-gu Seoul, KR
3014004349 Arthrex Singapore Pte Ltd. Singapore Central Singapore, SG
3020704423 Arthrex New Zealand Limited Auckland, NZ
3011230048 Arthrex Mexico, S.A. de C.V. Col. Napoles Mexico, MX

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
K203334 Acuitive Technologies, Inc. The Citrefix Knotless Suture Anchor 2021-02-05
K243467 Osteonic Co., Ltd. Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) 2024-12-03
K213415 OSSIO , Ltd. OSSIOfiber Suture Anchor 2022-03-28
K193295 Parcus Medical, LLC Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor 2020-01-23

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007193505. Last updated year: 2026. Please use registration number 3007193505 when referencing this establishment in official correspondence.
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