Data / Medical devices / Washer, Bolt, Nut, Non-Spinal, Metallic

Washer, Bolt, Nut, Non-Spinal, Metallic (NDG): 18 FDA-registered makers in 5 countries

Name: FDA-registered makers of Washer, Bolt, Nut, Non-Spinal, Metallic
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

18 establishments in 5 countries are registered with the FDA to make Washer, Bolt, Nut, Non-Spinal, Metallic (product code NDG, Class 2, 21 CFR 888.3030). 2 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on November 4, 2005, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code: NDG
Device class: 2
Regulation: 888.3030
Medical specialty: Orthopedic
Implant: Yes

Makers by country

Country	Makers
United States	10
Malaysia	4
Switzerland	2
South Korea	1
Taiwan	1

Makers of Washer, Bolt, Nut, Non-Spinal, Metallic

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Synthes GMBH	Zuchwil Solothurn, Switzerland	Specification developer	1	November 4, 2005	0	api.fda.gov
Synthes (USA) Products LLC	West Chester, PA, United States	Specification developer	1	November 4, 2005	0	api.fda.gov
Jeil Medical Corporation	Seoul, South Korea	Manufacturer	0		0	api.fda.gov
Jabil Inc. (Monument)	Monument, CO, United States	Contract manufacturer	0		0	api.fda.gov
Microware Precision Co., Ltd.	Taichung, Taiwan	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Quadm Technologies, LLC	Hamilton, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Smith & Nephew Inc.	Oklahoma City, OK, United States	Manufacturer	0		0	api.fda.gov
Smith & Nephew Orthopaedics AG	AARAU Aargau, Switzerland	Manufacturer	0		0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0		0	api.fda.gov
Straits Orthopaedics (MFG) Sdn Bhd	Simpang Ampat Pulau Pinang, Malaysia	Contract manufacturer	0		0	api.fda.gov
Straits Orthopaedics (MFG) Sdn Bhd	Perai Pulau Pinang, Malaysia	Contract manufacturer	0		0	api.fda.gov
Straits Orthopaedics (MFG) Sdn Bhd	Bandar Cassia Pulau Pinang, Malaysia	Contract manufacturer	0		0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0		0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0		0	api.fda.gov
Smith and Nephew Operations Sdn. Bhd	Penang Pulau Pinang, Malaysia	Manufacturer	0		0	api.fda.gov
Trimed, Inc.	Santa Clarita, CA, United States	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Trilliant Surgical LLC	Houston, TX, United States	Manufacturer	0		0	api.fda.gov
Zimmer, Inc.	Warsaw, IN, United States	Manufacturer	0		1	api.fda.gov

Updated November 4, 2005. 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.