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MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450178690·

Mariner Cortical

FDA UDI
Seaspine Orthopedics Corporation·10889987166667·CORTICAL SHANK, SOLID, 8.0 X 75

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306802348·Halsey Needle Holder, Serrated Jaws, 13cm

Mariner Cortical

FDA UDI
Seaspine Orthopedics Corporation·10889981166663·CORTICAL SHANK, SOLID, 8.0 X 75

Symmetry Malis®

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482139776·Symmetry® Forceps; Bayonet Bipolar; Insulated; ...

Cannulated Headless Compression Screw, 1/4 Threaded, 3.5mm x 75mm

FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665025088·

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810014604312·TABLE WIDTH EXTENDER PAD 20 X 4 X 1

TEKNIQUE

FDA 510(k)
FDA Class 2 ·Physical Medicine

MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 5, 2024

Apelo® / Apelo® MIS

FDA UDI
ATLAS SPINE, INC.·M68111000800750·5.5mm x 75mm Straight Secure Rod

Symmetry Malis®

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482139783·Forcep Bipolar Bayonet Angled 45 Deg Down Insul...

Invictus

FDA UDI
ALPHATEC SPINE, INC.·00190376502502·Cortical-Cancellous Extended Tab Polyaxial Redu...

Arsenal

FDA UDI
ALPHATEC SPINE, INC.·00844856084681·POLYAXIAL SCREW, 8.0mm X 75mm

Invictus

FDA UDI
ALPHATEC SPINE, INC.·00190376622101·Polyaxial Screw, 8.0mm X 75mm

Invictus

FDA UDI
ALPHATEC SPINE, INC.·00190376401577·Cannulated Iliac Favored Angle Screw, 8.0mm X 75mm

Invictus

FDA UDI
ALPHATEC SPINE, INC.·00190376492650·Cannulated Fixed Screw Ø8.0mm x 75mm

Invictus

FDA UDI
ALPHATEC SPINE, INC.·00190376682228·Cannulated Favored Angle Screw, 8.0mm X 75mm

Disposable Cuff

FDA UDI
SUNTECH MEDICAL, INC.·10840935100874·