KJ ZIRCONIA Implant System

FDA 510(k)

FDA Class 2 ·Dental

ARIX Ankle System

FDA 510(k)

FDA Class 2 ·Orthopedic

ARIX Wrist System

FDA 510(k)

FDA Class 2 ·Orthopedic

LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.

FDA 510(k)

FDA Class 2 ·Orthopedic

RMF-2000

FDA 510(k)

FDA Class 2 ·Radiology

LeForte System II

FDA 510(k)

FDA Class 2 ·Dental

EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG

FDA 510(k)

FDA Class 2 ·Radiology

EXTRON 3; EXTRON 5; EXTRON 7

FDA 510(k)

FDA Class 2 ·Radiology

TDM Lumbar Interbody Fusion Cage System

FDA 510(k)

FDA Class 2 ·Orthopedic

Dual Top Screw System

FDA 510(k)

FDA Class 2 ·Dental

PathLoc Lumbar Interbody Fusion Cage System

FDA 510(k)

FDA Class 2 ·Orthopedic

EXPD 4357; EXPD 4357P

FDA 510(k)

FDA Class 2 ·Radiology

EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM)

FDA 510(k)

FDA Class 2 ·Radiology

PathLoc-TA Expandable Lumbar Cage System

FDA 510(k)

FDA Class 2 ·Orthopedic

Alpha-D-Galactosidase A (Gla) Newborn Screening Test System

FDA classification

FDA Class 2 ·Alpha-D-Galactosidase A (Gla) Newborn Screening Test System

ARIX Cannulated Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

SD Abutment

FDA 510(k)

FDA Class 2 ·Dental

EXPD 4343S

FDA 510(k)

FDA Class 2 ·Radiology

EzOrtho

FDA 510(k)

FDA Class 2 ·Radiology

ARIX Wrist System

FDA 510(k)

FDA Class 2 ·Orthopedic