Data / Medical devices / Germany / GLW Europe GmbH

GLW Europe GmbH: FDA-registered device maker in Wurmlingen Baden-Wurttemberg, Germany, 7 510(k) clearances

Name: GLW Europe GmbH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

GLW Europe GmbH is registered with the FDA (registration 3026593233) in Wurmlingen Baden-Wurttemberg, Germany. It lists 23 device types. The FDA files 7 510(k) clearances under its listings, the newest dated December 4, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3026593233
Address: Max-Planck-Str.12, Wurmlingen Baden-Wurttemberg, Germany, 78573
Owner or operator: GLW, INC. (10058309)
Roles: Exporter to the US, Specification developer
First device listed: June 8, 2020
Registered through: 2026
Brand names listed: APOLLO Ankle Fracture Plates / 2.9mm / Locking Screw / 2.9 x 08mm - F3-1029-008, APOLLO Ankle Fracture Plates / 2.9mm / Locking Screw / 2.9 x 10mm - F3-1029-010, APOLLO Ankle Fracture Plates / 2.9mm / Locking Screw / 2.9 x 12mm - F3-1029-012, APOLLO Ankle Fracture Plates / 2.9mm / Locking Screw / 2.9 x 14mm - F3-1029-014, APOLLO Ankle Fracture Plates / 2.9mm / Locking Screw / 2.9 x 16mm - F3-1029-016, APOLLO Ankle Fracture Plates / 2.9mm / Locking Screw / 2.9 x 18mm - F3-1029-018, APOLLO Ankle Fracture Plates / 2.9mm / Locking Screw / 2.9 x 20mm - F3-1029-020, APOLLO Ankle Fracture Plates / 2.9mm / Locking Screw / 2.9 x 22mm - F3-1029-022 and more

Devices it lists

Device	Product code	Class	Role	Source
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	KTT	2	Exporter to the US	accessdata.fda.gov
Bit, Drill	HTW	1	Exporter to the US	accessdata.fda.gov
Burr, Orthopedic	HTT	1	Exporter to the US	accessdata.fda.gov
Countersink	HWW	1	Exporter to the US	accessdata.fda.gov
Elevator, Ent	KAD	1	Exporter to the US	accessdata.fda.gov
Forceps, Dressing, Dental	EFL	1	Exporter to the US	accessdata.fda.gov
Forceps, General & Plastic Surgery	GEN	1	Exporter to the US	accessdata.fda.gov
Gauge, Depth	HTJ	1	Exporter to the US	accessdata.fda.gov
Gouge, Surgical, General & Plastic Surgery	GDH	1	Exporter to the US	accessdata.fda.gov
Guide, Drill, Ligament	LXI	1	Exporter to the US	accessdata.fda.gov
Instrument, Bending Or Contouring	HXP	1	Exporter to the US	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Exporter to the US	accessdata.fda.gov
Instrument, Surgical, Non-Powered	HAO	1	Exporter to the US	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Exporter to the US, Specification developer	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Exporter to the US	accessdata.fda.gov
Retractor	GAD	1	Exporter to the US	accessdata.fda.gov
Rod, Fixation, Intramedullary And Accessories	HSB	2	Exporter to the US	accessdata.fda.gov
Scaler, Periodontic	EMN	1	Exporter to the US	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Exporter to the US, Specification developer	accessdata.fda.gov
Staple Driver	HXJ	1	Specification developer	accessdata.fda.gov
Staple, Fixation, Bone	JDR	2	Specification developer	accessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	2	Exporter to the US	accessdata.fda.gov
Template	HWT	1	Exporter to the US	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 4, 2023	K230724	arcad® 2.0 Duo & Quadro osteosynthesis compressive staples	JDR	Substantially Equivalent	Novastep	accessdata.fda.gov
January 25, 2023	K223847	CREED Cannulated Screws	HWC	Substantially Equivalent	Glw, Inc.	accessdata.fda.gov
October 27, 2022	K221489	Artemis Proximal Femoral Nail System	HSB	Substantially Equivalent	Glw, Inc.	accessdata.fda.gov
March 11, 2022	K213005	Apollo Ankle Fracture Plating System	HRS	Substantially Equivalent	Glw Medical, Inc.	accessdata.fda.gov
December 16, 2020	K200291	CREED Cannulated Screws	HWC	Substantially Equivalent	Glw Medical, Inc.	accessdata.fda.gov
September 14, 2020	K200343	FusionFrame Ring Lock System	KTT	Substantially Equivalent	Glw Medical Innovation	accessdata.fda.gov
July 5, 2013	K123234	ERMIS STERILIZATION CONTAINER SYSTEM	KCT	Substantially Equivalent	Ermis Medizintechnik	accessdata.fda.gov

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Updated December 4, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.