Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009468807

FEI Number

3009468807

Entity Name

MEDITEC SOURCE GmbH & Co. KG

City/State/Country

Tuttlingen-Nendingen Baden-Wurttemberg, DE

Establishment Address

Sattlerstrasse 19, Tuttlingen-Nendingen Baden-Wurttemberg 78532, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Meditec Source GmbH & Co. KG (Owner Number: 10041453)

Owner / Operator Contact Address

Sattlerstrasse 19, Tuttlingen-Nendingen, DE-BW 78532, 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
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2012-07-25
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2013-07-10
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2021-03-16
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2013-07-04
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	2013-07-08
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2014-09-04
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2012-07-25
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2026-04-14
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2017-03-07
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2014-02-27
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2021-11-19
HXW	Bender	Orthopedic	Class 1	888.4540	2016-10-25
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2019-07-23
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2013-01-10
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2013-01-30
FCZ	Tube, Smoke Removal, Endoscopic	Gastroenterology, Urology	Class 1	876.1500	2018-06-20
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2019-11-25
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-03-20
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2013-02-27
HTX	Rongeur	Orthopedic	Class 1	888.4540	2014-02-06
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2013-06-10
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2014-07-31
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2019-11-05

Official Correspondent

No official correspondent registered.

US Agent Details

Angelika Scherp Business: Business Support International Email: info@bsi-fda.com Phone: (212) 3318358

Related Public Records

Same Entity

Meditec Source GmbH & Co. KG

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
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02

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.

Similar Registrations

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3038187464	MIRACLUS ORTHOTECH PRIVATE LIMITED	Ahmedabad Gujarat, IN
3011513267	FLOSPINE LLC	Boca Raton, FL, US
3003882387	B. ALI IMPEX	SIALKOT, Punjab, PK
3008021110	Limacorporate S.p.A.	Villanova di San Daniele Udine, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009468807. Last updated year: 2026. Please use registration number 3009468807 when referencing this establishment in official correspondence.