FDA 510(k) Applications for Medical Device:
Retractor, Self-Retaining, For Neurosurgery

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K992898 BRIGHT MEDICAL INSTRUMENTS 799 N.E. 71ST ST.
BOCA RATON FL 33487
K090272 CARDINAL HEALTH, INC. 1430 WAUKEGAN ROAD- MPKB-2B
MCGAW PARK IL 60085
K062814 DEPUY SPINE, INC. 325 PARAMOUNT DR.
RAYNHAM MA 02767
K161004 FETZER MEDICAL GMBH & CO.KG UNTER BUCHSTEIG 5
Tuttlingen 78532
K180610 Geister Medizintechnik GmbH Forhenstrasse 2
Tuttlingen 78532
K071771 INSTRUMED INTERNATIONAL, INC. 626 COOPER COURT
SCHAUMBURG IL 60173
K112913 JOHNSON & JOHNSON 325 Paramount Drive
Raynham MA 02767
K113273 JOHNSON & JOHNSON 325 Paramount Drive
Raynham MA 02767
K093054 KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE.
EL SEGUNDO CA 90245
K060097 KLS-MARTIN L.P. 11239 ST. JOHNS INDUSTRIAL
JACKSONVILLE FL 32246
K071338 KOROS USA, INC. 610 FLINN AVE.
MOORPARK CA 93021
K161680 MEDICON EG GANSACKER 15
TUTTLINGEN 78532
K202072 Minnetronix Neuro, INC. 1635 Energy Park Drive
St. Paul MN 55108
K120691 NICO CORPORATION 250 E 96th St Ste 125
Indianapolis IN 46240
K172433 NICO Corporation 250 E 96TH St. Suite 125
Indianapolis IN 46240
K150378 NICO Corporation 250 E 96TH ST Suite 125
Indianapolis IN 46240
K960807 OHIO MEDICAL INSTRUMENT CO., INC. 3924 VIRGINIA AVE.
CINCINNATI OH 45227
K050706 SPINAL CONCEPTS, INC. 5301 RIATA PARK CT., BLDG. F
AUSTIN TX 78727
K161318 TEDAN SURGICAL INNOVATIONS LLC 12615 W. AIRPORT BLVD, SUITE 200
SUGAR LAND TX 77478
K210615 Thompson Surgical Instruments Inc. 10341 E Cherry Bend Rd
Traverse MI 49684
K964402 V. MUELLER NEURO/SPINE 871 INDUSTRIAL RD.
SAN CARLOS CA 94070
K202694 Vycor Medical INC. 951 Broken Sound Parkway, STE 320
Boca Raton FL 33487
K060973 VYCOR MEDICAL LLC 543 LONG HILL AVENUE
SHELTON CT 06484




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