FDA 510(k) Applications Submitted by MARY BIGGERS, RAC

FDA 510(k) Number Submission Date Device Name Applicant
K970400 02/03/1997 BONE SOURCE HYDROXYAPATITE ORTHOFIX, INC.
K950875 02/28/1995 OGDEN ANCHOR AMERICAN MEDICAL ELECTRONICS, INC.
K951232 03/20/1995 EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MM AMERICAN MEDICAL ELECTRONICS, INC.
K110805 03/23/2011 GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL) ORTHOFIX INC.
K951545 03/30/1995 OGDEN ANCHOR FOR ALL ORTHOPAEDIC SOFT TISSUE APPLICATIONS AMERICAN MEDICAL ELECTRONICS, INC.
K951493 03/31/1995 OGDEN ANCHOR AMERICAN MEDICAL ELECTRONICS, INC.
K931769 04/09/1993 SNAP OSCILLATING SAW SURGIQUIP, INC.
K031219 04/17/2003 MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR) ORTHOFIX, INC.
K952348 05/19/1995 OGDEN ANCHOR AMERICAN MEDICAL ELECTRONICS, INC.
K953339 07/17/1995 BONESOURCE HYDROXYAPATITE CEMENT (HAC) OSTEOGENICS, INC.
K102201 08/04/2010 CONTOURS LAPIDUS PLATING SYSTEM ORTHOFIX INC.
K935322 11/04/1993 SNAP BONE REAMER SURGIQUIP, INC.
K935357 11/04/1993 SNAP RECIPROCATING SAW SURGIQUIP, INC.
K093442 11/05/2009 GUIDED GROWTH SYSTEM ORTHOFIX INC.
K964537 11/12/1996 BONESOURCE HYDROXYAPATITE CEMENT (HAC) OSTEOGENICS, INC.
K935516 11/18/1993 SNAP DRILL SURGIQUIP, INC.
K935517 11/18/1993 SNAP STERNUM SAW SURGIQUIP, INC.
K101936 07/12/2010 CONTOURS VSP III VOLAR PLATING SYSTEM ORTHOFIX, INC.


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