Data / Medical devices / Malaysia / ZIMMER MEDICAL (Malaysia) SDN BHD

ZIMMER MEDICAL (Malaysia) SDN BHD: FDA-registered device maker in PETALING JAYA Selangor, Malaysia, 10 510(k) clearances

Name: ZIMMER MEDICAL (Malaysia) SDN BHD FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

ZIMMER MEDICAL (Malaysia) SDN BHD is registered with the FDA (registration 3015978338) in PETALING JAYA Selangor, Malaysia. It lists 19 device types. The FDA files 10 510(k) clearances under its listings, the newest dated December 8, 2020. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch ZIMMER MEDICAL (Malaysia) SDN BHD

FDA registration number: 3015978338
Address: Menara Symphony, 01-18, 18th Floor No 5 Jalan Prof. Khoo Kay Kim, Seksyen 13, PETALING JAYA Selangor, Malaysia, 46200
Owner or operator: Zimmer Biomet APAC DFE (10056128)
Roles: Exporter to the US
First device listed: January 4, 2026
Registered through: 2026
Brand names listed: A. L. P. S. Clavicle Plating System, Cable-Ready Cable Grip System; Cable-Ready Bone Plate System, Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables, EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE, G7 Acetabular System, LORENZ PECTUS SUPPORT BAR STABILIZER, Persona Revision Knee System, Taperloc Complete Hip Stems 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
Cerclage, Fixation	JDQ	2	Exporter to the US	accessdata.fda.gov
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	OQG	2	Exporter to the US	accessdata.fda.gov
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	OQI	2	Exporter to the US	accessdata.fda.gov
Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented	OQH	2	Exporter to the US	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Exporter to the US	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish	MAY	2	Exporter to the US	accessdata.fda.gov
Prosthesis, Elbow, Hemi-, Radial, Polymer	KWI	2	Exporter to the US	accessdata.fda.gov
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	KWZ	2	Exporter to the US	accessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal	KWL	2	Exporter to the US	accessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	KWY	2	Exporter to the US	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	LZO	2	Exporter to the US	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	JDI	2	Exporter to the US	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	LPH	2	Exporter to the US	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	MEH	2	Exporter to the US	accessdata.fda.gov
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	MBH	2	Exporter to the US	accessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	OIY	2	Exporter to the US	accessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	JWH	2	Exporter to the US	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	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 8, 2020	K200196	Taperloc® Complete Hip Stems	LZO	Substantially Equivalent	Biomet Orthopedics	accessdata.fda.gov
December 5, 2019	K190660	G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System Vivacit-E Vitamin E Highly Crosslinked Polyethylene	LPH	Substantially Equivalent	Zimmer, Inc.	accessdata.fda.gov
September 5, 2019	K191625	Persona Revision Knee System	JWH	Substantially Equivalent	Zimmer, Inc.	accessdata.fda.gov
April 6, 2018	K173767	A. L. P. S. Clavicle Plating System	HRS	Substantially Equivalent	Biomet, Inc.	accessdata.fda.gov
January 28, 2016	K151716	Cable-Ready Cable Grip System: Cable-Ready Bone Plate System	HRS	Substantially Equivalent	Zimmer, Inc.	accessdata.fda.gov
December 30, 2015	K151907	Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables	KTT	Substantially Equivalent	Zimmer, Inc.	accessdata.fda.gov
August 13, 2014	K141734	ZIMMER PERIARTICULAR LOCKING SYSTEM	HRS	Substantially Equivalent	Zimmer, Inc.	accessdata.fda.gov
May 16, 2012	K121149	VANGUARD SSK 360 REVISION KNEE SYSTEM	JWH	Substantially Equivalent	Biomet Manufacturing Corp	accessdata.fda.gov
August 5, 2005	K051385	EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE	KWI	Substantially Equivalent	Biomet, Inc.	accessdata.fda.gov
July 13, 1998	K981789	LORENZ PECTUS SUPPORT BAR STABILIZER	HRS	Substantially Equivalent	Walter Lorenz Surgical, Inc.	accessdata.fda.gov

Compare with other makers

Updated December 8, 2020. 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.