POLARUS MODULAR SHOULDER SYSTEM MANUFACTURED BY ACUMED LLC

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POLARUS MODULAR SHOULDER SYSTEM

Request for Information Form	Contact Information
Company Name	ACUMED LLC
Address	5885 NW CORNELIUS PASS RD.
City, State, Zip	HILLSBORO, OR 97124
Country	US
FDA Owner/Operator Phone	503-627-9957
FDA Medical Specialty Code	OR - Orthopedic
FDA Product Code	HSD
FDA Classification Name	PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
FDA Device Classification Code	Standards
FDA Regulation Number	888.3690
FDA Common Generic Name	MODULAR SHOULDER SYSTEM
FDA Proprietary Device Name	POLARUS MODULAR SHOULDER SYSTEM
FDA Owner / Operator Number	9001805
FDA Owner / Operator Name	ACUMED LLC
FDA Establishment Registration Number	3025141
FDA Registered Establishment Name	ACUMED LLC
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	03-05-01
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of ACUMED LLC

Our records indicate that the following medical device companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	ACCENTUS MEDICAL 528.10 UNITE 2, HARWELL BUSINESS CENTRE DIDCOT, OX11 0QJ UK 44-123-5434320 / 44-123-5434321	OXFORD MODULAR SHOULDER PROSTHESIS	OXFORD MODULAR SHOULDER PROSTHESIS
2	ARTHREX, INC. 1370 CREEKSIDE BLVD. NAPLES, FL 34108 US 239-643-5553 1244 / 239-643-5553 1244	UNIVERS SHOULDER	PROSTHESIS,SHOULDER,HEMI-,HUMERAL,METALLIC UNCEMENTED
3	ARTHROSURFACE, INC. 28 FORGE PARKWAY FRANKLIN, MA 02038 US 508-520-3003 / 508-520-3003 107	HEMICAP (TM) HUMERAL HEAD RESURFACING PROSTHESIS	SHOULDER JOINT HUMERAL (HEMI-SHOULDER) METALLIC RESURFACING PROSTHESIS
4	BIOMET UK LTD. MURDOCK ROAD DORCAN INDUSTRIAL ESTATE SWINDON WILTSHIRE, SN3 5HY UK 44-165-6655221 / 441-656-655221	BIOMET MERCK, COPELAND SHOULDER	STERILE RESURFACING SHOULDER JOINT REPLACEMENT PROSTHESIS
5	BIOMET UK LTD. WATERTON INDUSTRIAL ESTATE BRIDGEND SOUTH WALES, CF31 3XA UK 44-165-6655221 / 441-656-655221	BIOMET MERCK, COPELAND SHOULDER	STERILE RESURFACING SHOULDER JOINT REPLACEMENT PROSTHESIS
6	BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 WARSAW, IN 46581 US 574-267-6639 / 574-372-1742	MULTIPLE	VARIOUS TYPES OF STERILE AND NON-STERILE SHOULDER PROSTHESIS
7	DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. WARSAW, IN 46581 US 574-267-8143 4906 / 574-371-4906	GLOBAL SHOULDER	VARIOUS SHOULDER SYSTEM COMPONENTS
8	DVO EXTREMITY SOLUTIONS, LLC 720 E WINONA AVE WARSAW, IN 46580 US 877-777-9386 / 877-777-9386	TSA HUMERAL STEM, HUMERAL HEAD, GLENOID	HUMERAL STEM, HUMERAL HEAD, GLENOID
9	ENCORE MEDICAL, L.P. 9800 METRIC BLVD. AUSTIN, TX 78758 US 512-834-6225 / 512-834-6235	OTI SHOULDER SYSTEM	VARIOUS TYPES/SIZES MODULAR, NON-MODULAR HUMERAL COMP.
10	ENDOTEC, INC. 20 VALLEY STREET SOUTH ORANGE, NJ 07079 US 973-762-6100 / 973-762-6100	BUECHEL-PAPPAS HUMERAL STEM, HUMERAL HEAD	BUECHEL-PAPPAS HUMERAL STEM
11	EXACTECH, INC. 2320 N.W. 66TH CT. GAINESVILLE, FL 32653 US 352-377-1140 / 352-377-1140 150	MULTIPLE	HEMI-SHOULDER JOINT PROSTHESIS
12	HOWMEDICA INTERNATIONAL S. DE R.L., RAHEEN BUSNIESS PARK LIMERICK, EI 269-385-2600 / 201-831-5002	MULTIPLE	HUMERAL STEMS/HEADS
13	HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. MAHWAH, NJ 07430 US 269-385-2600 / 201-831-5002	MULTIPLE	HUMERAL STEMS/HEADS
14	PLUS ORTHOPEDICS AG ERLENSTRASSES 4A ROTKREUZ, CH-6343 SZ / 888-741-7587 2513	PROMOS SHOULDER	HEMI OR TOTAL SHOULDER - HUMERAL
15	PLUS ORTHOPEDICS AG SCHACHENALLEE 29 AARAU, CH-5000 SZ / 888-741-7587 2513	PROMOS SHOULDER	HEMI OR TOTAL SHOULDER - HUMERAL
16	SCANLAN INTERNATIONAL, INC. ONE SCANLAN PLAZA ST PAUL, MN 55107 US 651-298-0997 / 651-298-0997 152	MULTIPLE	MULTIPLE
17	SMITH & NEPHEW, INC. 1450 BROOKS RD. MEMPHIS, TN 38116 US 901-396-2121 / 901-399-5373	MULTIPLE	VARIOUS TYPES OF HUMERAL COMPONENTS
18	STRYKER IRELAND, LTD. OSTEONICS (ORTHOPAEDICS DIVI CARRIGTWOHILL INDUST. ESTATE CARRIGTWOHILL COUNTY CORK, EI 269-385-2600 / 201-831-5002	MULTIPLE	HUMERAL STEMS/HEADS
19	SYMMETRY MEDICAL THORNTON PRECISION COMPONENTS LTD BEULAH ROAD SHEFFIELD, SOUTH YORKSHIRE, S6 2AN UK 207-786-2775 / 44-114-2868809	MULTIPLE	SHOULDER PROSTHESIS
20	TECRES SPA VIA ANDREA DORIA 6 SOMMACAMPAGNA VERONA, 37066 IT 390-459-217311 / 390-459-217311	TECRES SPACER-S	TEMPORARY SHOULDER SPACER (WITH GENTAMICIN)
21	TORNIER RUE DOYEN GOSSE ST. ISMIER, 38330 FR 33-765-28000 / 33-04-76613500	AEQUALIS SHOULDER PROSTHESIS	SHOULDER PROSTHESIS
22	WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. ARLINGTON, TN 38002 US 901-867-4732 / 901-867-9971	INFINITY TOTAL SHOULDER SYSTEM	TOTAL SHOULDER PROTHESIS
23	ZIMMER GMBH SULZER ALLEE 8 WINTERTHUR, CH-8404 SZ / 574-372-4485	ANATOMICA PRESS-FIT HUMERAL STEM	PRESS-FIT HUMERAL STEM
24	ZIMMER, INC. 345 E. MAIN ST. WARSAW, IN 46580 US 800-613-6131 / 574-372-4485	MULTIPLE	VARIOUS TYPES OF SHOULDER PROSTHESES