Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8030965

FEI Number

3002807305

Entity Name

SYNTHES GMBH / Synthes Produktions GmbH

City/State/Country

Oberdorf, Baselland Basel-Landschaft, CH

Establishment Address

EIMATTSTRASSE 3, Oberdorf, Baselland Basel-Landschaft CH-4436, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SYNTHES GMBH / Synthes Produktions GmbH (Owner Number: 9071542)

Owner / Operator Contact Address

1301 Goshen Parkway, West Chester, PA 19380, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K053022

PMA Number

N/A

All Registered Proprietary Names

DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) HAMMERLOCK 2 Staple, fixation, bone SYNTHES (USA) RAPID RESORBABLE CRAN DePuy Synthes Femoral Recon Nail System screwdriver DePuy Synthes Hammertoe Continuous Compression Implant Synthes Angular Stable Locking System Synthes Angular Stable Locking Syst syringe SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM SYNTHES POLY (L-LACTIDE-CO-GLYCOLID Irrigation clips instrument TRAUMACEM" V+ Injectable Bone Cement Speed, Speed Shift, Speed Titan, Speed Arc VARIOUS RECHARGEABLE BATTERIES Synthes 90 Degree Screwdriver TORQUE LIMITING ATTACHMENT SPEED SHIFT SPEED TRIAD Synthes Air Pen Drive System VARIOUS BATTERY POWE KINCISE Orthomesh SPEED XL SYNTHES (USA) ELECTRIC PEN DRIVE SY tray blade FILLER, BONE VOID, CALCIUM COMPOUND surgical instrument bone grafting material

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HBW	Fastener, Plate, Cranioplasty	Neurology	Class 2	882.5360	2016-06-15
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2025-05-19
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-05-19
HBW	Fastener, Plate, Cranioplasty	Neurology	Class 2	882.5360	2008-01-02
GXR	Cover, Burr Hole	Neurology	Class 2	882.5250	2008-01-02
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2017-11-21
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2002-11-27
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-05-19
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2009-06-23
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2006-08-15
GXP	Methyl Methacrylate For Cranioplasty	Neurology	Class 2	882.5300	2006-08-15
JEY	Plate, Bone	Dental	Class 2	872.4760	2011-09-06
JEY	Plate, Bone	Dental	Class 2	872.4760	2008-01-02
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	1997-01-06
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2017-10-05
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-05-19
MOQ	Battery, Replacement, Rechargeable	General, Plastic Surgery	Class 1	878.4820	2001-02-07
DZJ	Driver, Wire, And Bone Drill, Manual	Dental	Class 2	872.4120	2009-05-06
DZI	Drill, Bone, Powered	Dental	Class 2	872.4120	2009-05-06
GFC	Driver, Surgical, Pin	General, Plastic Surgery	Class 1	878.4820	2002-11-27
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-05-19
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-05-19
HBB	Motor, Drill, Pneumatic	Neurology	Class 2	882.4370	2010-04-26
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2001-02-07
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2008-09-05
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2008-09-05
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-05-19
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2008-01-02
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2008-01-02
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2008-01-02
DZI	Drill, Bone, Powered	Dental	Class 2	872.4120	2008-01-02
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1996-06-18
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2002-10-11
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2015-01-08
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2002-10-11
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2006-08-15

Official Correspondent

No official correspondent registered.

US Agent Details

KAREN PARKER Email: kparker2@its.jnj.com Phone: (610) 7196567

Related Public Records

Same Entity

SYNTHES GMBH / Synthes Produktions GmbH

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013510178	Innomedic GmbH	Phillipsburg-Rheinsheim Baden-Wurttemberg, DE
3000270450	Synthes GMBH	Selzach Solothurn, CH
3009417901	SYNTHES GMBH	Zuchwil Solothurn, CH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K895079	Buckman Co., Inc.	ACE BEADED K-WIRES ACE OLIVE WIRES	1989-09-13
K922193	Osteo AG	OSTEO KIRSCHNER WIRE	1992-07-23
K850026	Kirkstil Corp., Inc.	ORTHOPEDIC IMPLANT NAILS & PINS	1985-05-20
K963367	Rms Div.	RMS K-WIRE	1996-10-30
K153770	In2bones Sas	OS2(R)-VP Varisation Staple	2016-03-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-05	Biomet, Inc.	2	Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.
Z-0008-2023	Synthes (USA) Products LLC	2	Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes

Similar Registrations

Registration Number	Establishment Name	Location
3009417901	SYNTHES GMBH	Zuchwil Solothurn, CH
8010177	STRYKER LEIBINGER GMBH & CO. KG	FREIBURG Baden-Wurttemberg, DE
3003477135	QUALITY TECH SERVICES, LLC	Bloomington, MN, US
1221485	Viant AS&O Holdings, LLC	LACONIA, NH, US
3008868758	EXEL INC. DBA DHL SUPPLY CHAIN (USA)	Mooresville, IN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030965. Last updated year: 2026. Please use registration number 8030965 when referencing this establishment in official correspondence.