Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006085220

FEI Number

3006085220

Entity Name

E. BAC SI IMPORTS LLC

City/State/Country

Ellensburg, WA, US

Establishment Address

631 Canyon Rivers Edge Road, Ellensburg, WA 98926, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

E. BAC SI IMPORTS LLC (Owner Number: 9089402)

Owner / Operator Contact Address

110 W. 6th Ave, Suite 342, Ellensburg, WA 98926, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Buechel-Pappas Humeral Head Resurfacing Component Cervical Collar Brace Shoulder Immobilizer Buechel-Pappas Hemispherical Acetabular Component New Jersey Acetabular Component and New Jersey Cancellous Bone Screws Femoral Heads/Modular Fixed with Titanium Nitride Ankle Brace With Stays; Knee Immobilizer Arm Sling Preserve Acetabular Cup Modified O.E.C Universal Self-Aligning Acetabular Component Buechel-Pappas Polyethylene Glenoid Component Buechel-Pappas Extended Collar Femoral Stem Prosthesis Wrist Brace, Tennis Elbow Strap Rib Belt CPM Pad Thumb Spica Splint

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2025-05-08
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2012-12-17
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2025-05-08
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2025-05-08
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2025-05-08
LZY	Prosthesis, Hip, Hemi-, Femoral, Metal Ball	Orthopedic	Class 2	888.3360	2025-05-08
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2012-12-17
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2012-12-17
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2026-04-22
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2025-05-08
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2025-05-08
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2025-05-08
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2012-12-17
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2012-12-17
BXB	Exerciser, Powered	Physical Medicine	Class 1	890.5380	2012-12-17
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2012-12-17

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

E. BAC SI IMPORTS LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K984202	Howmedica, Inc.	HOWMEDICA HUMERAL INTERCALARY SYSTEM	1999-02-05
K860442	Howmedica Corp.	PRECISION HIP SYSTEM PROXIMAL FEMORAL SPACER #6259	1986-05-06
K973124	Sulzer Orthopedics, Inc.	APR POROUS HA HIP SYSTEM	1997-11-03
K940328	Orthopaedic Innovations, Inc.	PRIME CEMENTED HIP SYSTEM	1995-04-07
K950761	Biomet, Inc.	INDEX ACETABULAT COMPONENT	1995-05-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
Z-0012-2019	Exactech, Inc.	2	Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery

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1226544	MILLSTONE MEDICAL OUTSOURCING LLC.	FALL RIVER, MA, US
3006017180	BBF STERILISATIONSSERVICE GMBH	Kernen Baden-Wurttemberg, DE
3011943495	PRECIMADE	Bourg en Bresse Ain, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006085220. Last updated year: 2026. Please use registration number 3006085220 when referencing this establishment in official correspondence.