ELECSYS IGE II IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

SYNTHES (USA) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR

FDA 510(k)

FDA Class 2 ·Orthopedic

EBI XFIX DFS METAPHYSEAL CORRECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MONET Anterior Cervical Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

Zavation ALIF System

FDA 510(k)

FDA Class 2 ·Orthopedic

STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

BONE OR INTERFERENCE SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD

FDA 510(k)

FDA Class 2 ·Orthopedic

PROMOS MODULAR SHOULDER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

S4 SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

AEQUALIS RESURFACING HEAD

FDA 510(k)

FDA Class 2 ·Orthopedic

THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO SCORPIO NRG KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

REVELATION AND LINEAR HIP STEMS AND FMP ACETABULAR SHELLS (SPIKED, HEMISPHERICAL AND FLARED)

FDA 510(k)

FDA Class 2 ·Orthopedic

Genesys Spine 3DP Cervical Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

VariAx Foot

FDA 510(k)

FDA Class 2 ·Orthopedic

Humeral Cup Stability & Humeral Cup 135/145o Stability

FDA 510(k)

FDA Class 2 ·Orthopedic