Data / Medical devices / United States / ARCH Medical Solutions - Escondido LLC

ARCH Medical Solutions - Escondido LLC: FDA-registered device maker in Escondido, CA, United States, 17 510(k) clearances

Name: ARCH Medical Solutions - Escondido LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

ARCH Medical Solutions - Escondido LLC is registered with the FDA (registration 2029005) in Escondido, CA, United States. It lists 10 device types. The FDA files 17 510(k) clearances under its listings, the newest dated May 13, 2016. 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 ARCH Medical Solutions - Escondido LLC

FDA registration number: 2029005
FEI number: 1000160570
Address: 950 Borra Place, Escondido, CA, United States, 92029
Owner or operator: ARCH Medical Solutions - Escondido LLC (9098779)
Roles: Manufacturer
First device listed: December 21, 2012
Registered through: 2026
Brand names listed: ARCH Medical Solutions Escondido, Abutment, implant, dental, endosseous, Accessories, implant, dental, endosseous, IMPLANT, ENDOSSEOUS, ROOT-FORM, Intervertebral fusion device with bone graft, cervical, Orthopedic manual surgical instrument, PLATE, BONE, Pedicle screw spinal system, adolescent idiopathic scoliosis

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Manufacturer	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Manufacturer	accessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral Body	KWQ	2	Manufacturer	accessdata.fda.gov
Implant, Endosseous, Root-Form	DZE	2	Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	2	Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Manufacturer	accessdata.fda.gov
Orthosis, Spinal Pedicle Fixation	MNI	2	Manufacturer	accessdata.fda.gov
Orthosis, Spondylolisthesis Spinal Fixation	MNH	2	Manufacturer	accessdata.fda.gov
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	OSH	2	Manufacturer	accessdata.fda.gov
Plate, Bone	JEY	2	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
May 13, 2016	K160154	ALTA Anterior Cervical Interbody Spacer	ODP	Substantially Equivalent	Astura Medical	accessdata.fda.gov
April 8, 2016	K153446	OLYMPIC Posterior Spinal Fixation System	OSH	Substantially Equivalent	Astura Medical	accessdata.fda.gov
December 12, 2013	K123861	AIDI DENTAL IMPLANT SYSTEM	DZE	Substantially Equivalent	Aidi Biomedical, LLC	accessdata.fda.gov
November 8, 2012	K120873	ZIMMER ZFX ABUTMENT FOR NOBEL REPLACE IMPLANT SYSTEM	NHA	Substantially Equivalent	Zimmer Dental, Inc.	accessdata.fda.gov
September 7, 2012	K120875	B&W DENTAL IMPLANT SYSTEM	DZE	Substantially Equivalent	B&W Srl	accessdata.fda.gov
November 22, 2010	K101755	AIDI DENTAL IMPLANT SYSTEM	DZE	Substantially Equivalent	Aidi Biomedical, LLC	accessdata.fda.gov
July 21, 2010	K101255	ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM	KWQ	Substantially Equivalent	Alphatec Spine, Inc.	accessdata.fda.gov
November 30, 2009	K092341	LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION	NHA	Substantially Equivalent	Biomet 3i, Inc.	accessdata.fda.gov
November 7, 2008	K081806	IDI IMPLANT SYSTEM	DZE	Substantially Equivalent	Idi Biomedical, LLC	accessdata.fda.gov
December 20, 2007	K072642	BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS	NHA	Substantially Equivalent	Biomet 3i, Inc.	accessdata.fda.gov
October 13, 2005	K052600	ZIMMER DENTAL HEX-LOCK PREPARED ABUTMENT (STRAIGHT & ANGLED)	NHA	Substantially Equivalent	Zimmer Dental, Inc.	accessdata.fda.gov
March 20, 2002	K014175	SULZER DENTAL CERAMIC SYSTEM-HEXLOCK	NHA	Substantially Equivalent	Sulzer Dental, Inc.	accessdata.fda.gov
September 18, 2001	K012413	MACROPORE FX, PS, NS, LP	JEY	Substantially Equivalent	Macropore Biosurgery, Inc.	accessdata.fda.gov
May 21, 2001	K011028	SCREW-VENT DENTAL IMPLANT SYSTEM	DZE	Substantially Equivalent	Sulzer Dental, Inc.	accessdata.fda.gov
January 19, 2001	K010073	SPLINE DENTAL IMPLANT SYSTEM	DZE	Substantially Equivalent	Sulzer Calcitek, Inc.	accessdata.fda.gov
December 8, 2000	K002614	ADVENT IMPLANT SYSTEM	DZE	Substantially Equivalent	Core-Vent Corp.	accessdata.fda.gov
September 22, 1998	K982305	SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENT	DZE	Substantially Equivalent	Sulzer Calcitek, Inc.	accessdata.fda.gov

Compare with other makers

Updated May 13, 2016. 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.