MULTIPLE MANUFACTURED BY SYNTHES (USA)

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MULTIPLE

Request for Information Form	Contact Information
Company Name	SYNTHES (USA)
Address	1051-1101 SYNTHES AVE.
City, State, Zip	MONUMENT, CO 80132
Country	US
FDA Owner/Operator Phone	610-719-5000
FDA Medical Specialty Code	NE - Neurology
FDA Product Code	GXR
FDA Classification Name	COVER, BURR HOLE
FDA Device Classification Code	Standards
FDA Regulation Number	882.5250
FDA Common Generic Name	VARIOUS TYPES AND SIZES OF BURR HOLE COVERS
FDA Proprietary Device Name	MULTIPLE
FDA Owner / Operator Number	2520274
FDA Owner / Operator Name	SYNTHES (USA)
FDA Establishment Registration Number	1719045
FDA Registered Establishment Name	SYNTHES (USA)
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	05-15-02
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of SYNTHES (USA)

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	AESCULAP AG & CO. KG. AM AESCULAP PLATZ TUTTLINGEN, DONAU, D-78532 GM 49-74-6195-1548 / 610-984-9074	MULTIPLE	VARIOUS
2	BIOPLATE, INC. 3643 LENAWEE AVE. LOS ANGELES, CA 90016 US 310-815-2100 / 310-815-2100	BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY	BURR HOLE COVER
3	BIOPLATE, INC. 3643 LENAWEE AVE. LOS ANGELES, CA 90016 US 310-815-2100 / 310-815-2100	BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY	BURR HOLE COVER
4	CODMAN & SHURTLEFF, INC. 325 PARAMOUNT DR. RAYNHAM, MA 02767 US 508-828-3704 / 508-828-3704	MULTIPLE	VARIOUS TYPES OF BURR HOLE COVERS
5	INTEGRA LIFESCIENCES CORPORATION 4900 CHARLEMAR DR., BUILDING A CINCINNATI, OH 45227 US 609-275-0500 / 513-533-7923	KRANIOS BURR HOLE COVERS	BURR HOLE COVERS
6	MEDOS SARL RUE GIRARDET 29 LE LOCLE, CH-2400 SZ 508-828-3704 / 508-828-3704	MULTIPLE	VARIOUS TYPES OF BURR HOLE COVERS
7	MEDTRONIC IMAGE-GUIDED NEUROLOGICS, INC. 2290 WEST EAU GALLIE BLVD. MELBOURNE, FL 32935 US 321-757-8990 / 763-505-0323	NAVIGUS BASE AND CAP	BURR HOLE COVER
8	MEDTRONIC NEUROSURGERY 125 CREMONA DR. GOLETA, CA 93117 US 763-514-4000 / 805-968-1546 1770	MULTIPLE MODELS	MULTIPLE TYPES OF BURR HOLE COVER
9	MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE MEMPHIS, TN 38132 US 763-514-4000 / 901-344-1538	TIMESH SYSTEM	TIMESH SYSTEM
10	POREX SURGICAL, INC. 15 DART RD. NEWNAN, GA 30265 US 770-964-1421 / 678-479-1610 602	MEDPOR SURGICAL IMPLANT, CYLINDER SHAPES	BURR HOLE COVER
11	STRYKER LEIBINGER GMBH & CO. KG BOTZINGER STRASSE 41 FREIBURG, D-79111 GM 269-385-2600 / 49-761-4512x185	LEIBINGER BURR HOLE COVERS	BURR HOLE COVER
12	SYNTHES (USA) 35 AIRPORT RD. HORSEHEADS, NY 14845 US 610-719-5000 / 484-356-9728	MULTIPLE	VARIOUS TYPES AND SIZES OF BURR HOLE COVERS
13	SYNTHES GMBH EIMATTSTRASSE 3 OBERDORF, CH-4436 SZ 41-32-6441644 / 41-61-965 62 22	MULTIPLE	VARIOUS TYPES AND SIZES OF BURR HOLE COVERS
14	SYNTHES MEZZOVICO GMBH ZONA INDUSTRIALE 4 MEZZOVICO, CH-6805 SZ 41-32-6441644 / 41-61-965 62 22	MULTIPLE	VARIOUS TYPES AND SIZES OF BURR HOLE COVERS
15	UNION MEDICAL S.A. CALLE 46 A SUR NO. 49-124 MEDELLIN, CO 574-332-9007 / 574-332-9007	BIO SAFE	COVER, BURR HOLE
16	VYGON NEURO 2495 GENERAL ARMISTEAD AVE. NORRISTOWN, PA 19403 US 610-539-9300 / 610-539-9300 110	MULTIPLE	VARIOUS
17	W.L. GORE & ASSOCIATES,INC 1505 NORTH FOURTH ST. FLAGSTAFF, AZ 86003 US 302-738-4880 / 928-864-4736	GORE BURR HOLE COVER	BURR HOLE COVER

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