FDA 510(k) Applications for Medical Device:
Drills, Burrs, Trephines & Accessories (Simple, Powered)

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K170442 Ad-Tech Medical Instrument Corporation 1901 William Street
Racine WI 53404
K130755 ADEOR MEDICAL AG KIRCHPLATZ 1
PULLACH 82049
K191479 adeor Medical AG Biberger Str. 93
Unterhaching 82008
K203739 Aesculap Inc. 3773 Corporate Parkway
Center Valley PA 18034
K022942 AESCULAP, INC. 3773 Corporate Parkway
Center Valley PA 18034
K172709 Aesculap, Inc. 3773 Corporate Parkway
Center Valley PA 18034
K182527 Aesculap, Inc. 3773 Corporate Parkway
Center Valley PA 18034
K183203 Aesculap, Inc. 3773 Corporate Parkway
Center Valley PA 18034
K213072 Biomet Micofixation 1520 Tradeport Drive
Jacksonville FL 32218
K223199 Biomet Microfixation 1520 Tradeport Drive
Jacksonville FL 32218
K213208 Biomet Microfixation 1520 Tradeport Drive
Jacksonville FL 32218
K161704 BIOTEX, INC. 114 HOLMES RD
HOUSTON TX 77045
K030172 BRASSELER USA I, L.P. 4837 MCGRATH ST., SUITE J
VENTURA CA 93003
K153519 CAREVATURE MEDICAL LTD 42 Tvuot Haarets St.
Tel Aviv 6954648
K230619 Hubly Inc. 750 Warrenville Rd
Lisle IL 60532
K984035 KOMET MEDICAL 1679 KELLOGG SPRINGS DR.
ATLANTA GA 30338
K072315 MEDTRONIC POWERED SURGICAL SOLUTIONS 4620 NORTH BEACH ST.
FORT WORTH TX 76137
K213454 Medtronic Powered Surgical Solutions 4620 North Beach Street
Fort Worth TX 76137
K123270 MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE
MEMPHIS TN 38132
K182436 Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place
Memphis TN 38132
K121264 MEDTRONIC SURGICAL TECHNOLOGIES 4620 NORTH BEACH STREET
FORT WORTH TX 76137
K081475 MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH
JACKSONVILLE FL 32216
K111520 MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH
JACKSONVILLE FL 32216
K014060 MICROAIRE SURGICAL INSTRUMENTS, INC. 1641 EDLICH DR.
CHARLOTTESVILLE VA 22911
K132436 MRI INTERVENTIONS, INC. 5 MUSICK
IRVINE CA 92618
K202120 Nakanishi Inc. 700 Shimohinata
Kanuma 322-8666
K162542 OSTEOMED 3885 ARAPAHO ROAD
ADDISON TX 75001
K190172 Stryker 4100 E. Milham Ave
Kalamazoo MI 49001
K143320 STRYKER CORP. 4100 E. MILHAM AVE.
KALAMAZOO MI 49001
K143399 STRYKER CORP. 4100 E. MILHAM AVE.
KALAMAZOO MI 49002
K210377 Stryker Corporation 1941 Stryker Way
Portage MI 49002
K191049 Stryker Corporation 4100 E Milham Ave
Kalamazoo MI 49001
K143540 STRYKER CORPORATION 4100 E. MILHAM AVE.
KALAMAZOO MI 49001
K070876 STRYKER CRANIOMAXILLOFACIAL 750 TRADE CENTRE WAY
KALAMAZOO MI 49002
K032303 STRYKER INSTRUMENTS 4100 EAST MILHAM AVE.
KALAMAZOO MI 49001
K040076 THE ANSPACH EFFORT, INC. 4500 RIVERSIDE DR.
PALM BEACH GARDENS FL 33410
K002903 THE ANSPACH EFFORT, INC. 4500 RIVERSIDE DR.
PALM BEACH GARDENS FL 33410
K050628 THE ANSPACH EFFORT, INC. 4500 RIVERSIDE DR.
PALM BEACH GARDENS FL 33410
K113476 THE ANSPACH EFFORT, INC. 4500 RIVERSIDE DR.
Palm Bch Gdns FL 33410
K183545 The Anspach Effort, Inc. 4500 Riverside Drive
Palm Beach Gardens FL 33410
K042783 THE ANSPACH EFFORT, INC. 4500 RIVERSIDE DR.
PALM BEACH GARDENS FL 33410
K080802 THE ANSPACH EFFORT, INC. 4500 RIVERSIDE DR.
PALM BEACH GARDENS FL 33410
K062842 WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR.
JACKSONVILLE FL 32218




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