Data / Medical devices / United States / E. Bac Si Imports LLC

E. Bac Si Imports LLC: FDA-registered device maker in Ellensburg, WA, United States, 11 510(k) clearances

Name: E. Bac Si Imports LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

E. Bac Si Imports LLC is registered with the FDA (registration 3006085220) in Ellensburg, WA, United States. It lists 16 device types. The FDA files 11 510(k) clearances under its listings, the newest dated October 15, 1999. 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 E. Bac Si Imports LLC

FDA registration number: 3006085220
Address: 631 Canyon Rivers Edge Road, Ellensburg, WA, United States, 98926
Owner or operator: E. BAC SI IMPORTS LLC (9089402)
Roles: Complaint file establishment, Specification developer
First device listed: December 17, 2012
Registered through: 2026
Brand names listed: Ankle Brace With Stays; Knee Immobilizer, Arm Sling, Buechel-Pappas Extended Collar Femoral Stem Prosthesis, Buechel-Pappas Hemispherical Acetabular Component, Buechel-Pappas Humeral Head Resurfacing Component, Buechel-Pappas Humeral Stem Component, Buechel-Pappas Polyethylene Glenoid Component, CPM Pad and more

Devices it lists

Device	Product code	Class	Role	Source
Components, Exercise	IOD	1	Specification developer	accessdata.fda.gov
Exerciser, Powered	BXB	1	Specification developer	accessdata.fda.gov
Joint, Knee, External Brace	ITQ	1	Specification developer	accessdata.fda.gov
Orthosis, Cervical	IQK	1	Specification developer	accessdata.fda.gov
Orthosis, Limb Brace	IQI	1	Specification developer	accessdata.fda.gov
Orthosis, Truncal/Orthosis, Limb	MRI	1	Specification developer	accessdata.fda.gov
Prosthesis, Hip, Femoral, Resurfacing	KXA	2	Specification developer	accessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal	KWL	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal Ball	LZY	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	JDI	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	LPH	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	HSD	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	KWT	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	KWS	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Sling, Arm	ILI	1	Specification developer	accessdata.fda.gov
Splint, Hand, And Components	ILH	1	Specification developer	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
October 15, 1999	K992394	BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT	HSD	Substantially Equivalent	Endotec, Inc.	accessdata.fda.gov
February 12, 1997	K963101	B-P HEMISPHERICAL ACETABULAR COMPONENT	LPH	Substantially Equivalent	Endotec, Inc.	accessdata.fda.gov
February 12, 1997	K963100	TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF ACE. CUP	LPH	Substantially Equivalent	Endotec, Inc.	accessdata.fda.gov
August 26, 1996	K960424	BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD	KWT	Substantially Equivalent	Endotec, Inc.	accessdata.fda.gov
May 19, 1993	K905262	BUECHEL-PAPPAS EXTENDED COLLAR FEMORAL STEM PROSTH	JDI	Substantially Equivalent for Some Indications	Endotec, Inc.	accessdata.fda.gov
May 23, 1991	K904870	MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON	KXA	Substantially Equivalent	Endotec, Inc.	accessdata.fda.gov
January 28, 1991	K904880	BUECHEL-PAPPAS HUMERAL STEM COMPONENT	KWS	Substantially Equivalent	Endotec, Inc.	accessdata.fda.gov
July 19, 1989	K892059	FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR	LZY	Substantially Equivalent	Protek, Inc.	accessdata.fda.gov
February 27, 1989	K884889	MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP.	KWL	Substantially Equivalent	Protek, Inc.	accessdata.fda.gov
December 29, 1988	K884888	MODIFIED NEW JERSEY ACETABULAR COMP. & BONE SCREWS	JDI	Substantially Equivalent for Some Indications	Protek, Inc.	accessdata.fda.gov
July 20, 1984	K842202	NEW JERSEY ACETABULAR COMPONENT &	JDI	Substantially Equivalent	Endomedics, Inc.	accessdata.fda.gov

Compare with other makers

Updated October 15, 1999. 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.