HTR-PMI MANUFACTURED BY BIOMET, INC.

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HTR-PMI

Request for Information Form	Contact Information
Company Name	BIOMET, INC.
Address	56 EAST BELL DR. P.O. BOX 587
City, State, Zip	WARSAW, IN 46581
Country	US
FDA Owner/Operator Phone	574-267-6639
FDA Medical Specialty Code	NE - Neurology
FDA Product Code	GXN
FDA Classification Name	PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
FDA Device Classification Code	Standards
FDA Regulation Number	882.5330
FDA Common Generic Name	HARD TISSUE REPLACEMENT, PATIENT MATCHED IMPLANT
FDA Proprietary Device Name	HTR-PMI
FDA Owner / Operator Number	1825034
FDA Owner / Operator Name	BIOMET, INC.
FDA Establishment Registration Number	1825034
FDA Registered Establishment Name	BIOMET, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	12-21-93
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of BIOMET, INC.

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	BIOMET MICROFIXATION, INC. 1520 TRADEPORT DR. JACKSONVILLE, FL 32218 US 800-874-7711 / 904-741-9258	HTR-PMI	HARD TISSUE REPLACEMENT-PATIENT MATCHED IMPLANT
2	BIOPLATE, INC. 3643 LENAWEE AVE. LOS ANGELES, CA 90016 US 310-815-2100 / 310-815-2100	THE BIOPLATE (R) ZIP (TM) CRANIOTOMY FIXATION SYSTEM	CRANIOTOMY FIXATION SYSTEM
3	GENETIS S.A. 48, ROUTE DE DIVONNE NYON, 1260 SZ 41-223-625055 / 612-559-8205	MULTIPLE	VARIOUS SIZES OF CRANIOFACIAL IMPLANTS
4	INSTITUTE OF TECHNICAL SCIENCES OF THE ACADEMY KNEZ, MIHAILOVA 35/IV BELGRADE, YUGOSLAVIA, 11000 SR 381-11-185437 / 212-787-6900	PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE	CRANIO FACIAL IMPLANTS
5	KARL LEIBINGER GMBH U. CO. KG KOLBINGER STR. 10 MUHLHEIM, D-78570 GM 011-497-463838110 / 800-625-1557	PATIENT CONTOURED MESH	PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE
6	KOKEN CO., LTD. 3-14-3 MEJIRO, MEJIRO TOYO BLDG. TOSHIMA-KU, TOKYO, 171 JA 33-950-6600 / 33-950-6600	POREX SILICONE SURGICAL IMPLANTS MALAR	SILICONE MALAR IMPLANT
7	MEDTRONIC NEUROSURGERY 125 CREMONA DR. GOLETA, CA 93117 US 763-514-4000 / 805-968-1546 1770	MULTIPLE MODELS	MULTIPLE TYPES OF CRANIOPLASTY PLATE
8	OSTEOMED L.P. 3885 ARAPAHO RD. ADDISON, TX 75001 US 972-677-4600 / 972-677-4787	OSTEOFLAP CRANIAL FLAP FIXATION SYSTEM	BONE PLATES
9	STRYKER LEIBINGER MICRO IMPLANTS 750 TRADE CENTRE WAY SUITE 200 PORTAGE, MI 49002 US 269-385-2600 / 269-323-4226	QUIKDISK	CRANIOPLASTY PLATE
10	SYNTHES (USA) 1301-1303 GOSHEN PKWY. WEST CHESTER, PA 19380 US 610-719-5000 / 484-356-9728	MULTIPLE	VARIOUS TYPES AND SIZES OF PREFORMED NONALTERABLE CRANIOPLASTY PLATES
11	SYNTHES (USA) 1051-1101 SYNTHES AVE. MONUMENT, CO 80132 US 610-719-5000 / 484-356-9728	MULTIPLE	PREFORMED NONALTERABLE CRANIOPLASTY PLATE
12	SYNTHES GMBH EIMATTSTRASSE 3 OBERDORF, CH-4436 SZ 41-32-6441644 / 41-61-965 62 22	PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE (MULTIPLE BRANDS)	PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE (VARIOUS TYPES AND SIZES
13	SYNTHES MEZZOVICO GMBH ZONA INDUSTRIALE 4 MEZZOVICO, CH-6805 SZ 41-32-6441644 / 41-61-965 62 22	MULTIPLE	VARIOUS TYPES AND SIZES OF PREFORMED,NON-ALTERABLE CRANIOPLASTY PLATES
14	TMJ IMPLANTS, INC. 17301 WEST COLFAX AVE., SUITE 135 GOLDEN, CO 80401 US 303-277-1338 / 303-277-1338	NO PROPRIETARY NAME LISTED	PROSTHESIS, FACIAL, IMMOBILE