Data / Medical devices / United States / Jewel Precision Sheet Metal & Machining, Inc.

Jewel Precision Sheet Metal & Machining, Inc.: FDA-registered device maker in Cedar Grove, NJ, United States, 1 510(k) clearance

Name: Jewel Precision Sheet Metal & Machining, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Jewel Precision Sheet Metal & Machining, Inc. is registered with the FDA (registration 3004112448) in Cedar Grove, NJ, United States. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 9, 2016. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3004112448
Address: 200 Commerce RD, Cedar Grove, NJ, United States, 07009
Owner or operator: JEWEL PRECISION (9057472)
Roles: Contract manufacturer, Manufacturer
First device listed: October 23, 2012
Registered through: 2026
Brand names listed: JP-24-6 Jewel Precision Rigid Reusable Sterilization Container System, SIOS Surgical Instrument Organizing System

Devices it lists

Device	Product code	Class	Role	Source
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Contract manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Thoracic	PHM	2	Contract manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, Lumbar	OVD	2	Contract manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Contract manufacturer	accessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	2	Manufacturer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Contract manufacturer, Manufacturer	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 9, 2016	K162600	Jewel Precision Reusable Rigid Sterilization Container System	KCT	Substantially Equivalent	Jewel Precision Sheet Metal & Machine, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
May 23, 2025	96958	Class II	Ongoing	Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.	The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was not cleared by the FDA. The letter to file justifying the change in size was insufficient.	accessdata.fda.gov
May 22, 2025	96957	Class II	Ongoing	Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.	The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.	accessdata.fda.gov

Compare with other makers

Updated June 26, 2025. 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.