FDA 510(k) Applications for Medical Device:
Prosthesis, Wrist, Hemi-, Ulnar

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K190599 Aptis Medical, LLC 3602 Glenview Ave.
Glenview KY 40025
K142569 APTIS MEDICAL, LLC. 3602 GLENVIEW AVE.
GLENVIEW KY 40025
K082839 APTIS MEDICAL, LLC. 3602 GLENVIEW AVE.
GLENVIEW KY 40025
K053119 APTIS MEDICAL, LLC. 5 RIVER HILL RD.
LOUISVILLE KY 40207
K040497 APTIS MEDICAL, LLC. P.O. BOX 249
DEL MAR CA 92014
K112481 ASCENSION ORTHOPEDIC 8700 CAMERON RD., STE. 100
Austin TX 78754
K052137 ASCENSION ORTHOPEDICS, INC. 8700 CAMERON RD., STE. 100
AUSTIN TX 78754-3832
K010786 AVANTA ORTHOPAEDICS, INC. 9369 CARROLL PARK DRIVE, STE.A
SAN DIEGO CA 92121
K982268 AVANTA ORTHOPAEDICS, INC. 9369 CARROLL PARK DRIVE, STE.A
SAN DIEGO CA 92121
K033930 KAPP SURGICAL INSTRUMENT, INC. 4919 WARRENSVILLE CENTER RD.
CLEVELAND OH 44128
K081025 REMI SCIENCES, INC. 745 BENT CREEK DRIVE
LITITZ PA 17543
K061146 SMALL BONE INNOVATIONS INC. 505 PARK AVE., 14TH FLOOR
NEW YORK NY 10022
K042902 STUCKENBROCK MEDIZINTECHNIK GMBH 12244 SW 130 ST.
MIAMI FL 33186
K020274 WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD.
ARLINGTON TN 38002




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