Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ENZYMUN-TEST{R} AFP

SONICWELD RX (RESORB-X)

FDA 510(k)

FDA Class 2 ·Dental

ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38

FDA 510(k)

FDA Class 2 ·Orthopedic

STINGRAY CERVICAL CAGE; SHARK IMPLANT (PLIF); BULL SHARK IMPLANT(PLIF); TIGER IMPLANT (TLIF); GREAT WHITE IMPLANTS(ALIF)

FDA 510(k)

FDA Class 2 ·Orthopedic

RSP MODULAR GLENOID BASEPLATE, GLENOID TAPER ADAPTER, RETAINING SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

KLS-MARTIN TEMPORARY CONDYLAR IMPLANT

FDA 510(k)

FDA Class 2 ·Dental

KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

RSP MONOBLOCK STEM WITH P2 COATING, SIZE 6

FDA 510(k)

FDA Class 2 ·Orthopedic

ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15

FDA 510(k)

FDA Class 2 ·Dental

EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)

FDA 510(k)

FDA Class 2 ·Orthopedic

EV APAN DIGITAL, MODEL K1VSM2000

FDA 510(k)

FDA Class 2 ·Dental

KLS Martin Individual Patient Solutions (IPS) Planning System

FDA 510(k)

FDA Class 2 ·Orthopedic

ENCORE KNEE SYSTEM IFU

FDA 510(k)

FDA Class 2 ·Orthopedic

KLS Martin Pure Pectus System

FDA 510(k)

FDA Class 2 ·Orthopedic

REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM

FDA 510(k)

FDA Class 2 ·Orthopedic

REVELATION POROUS COATED HIP STEM, SIZE 8

FDA 510(k)

FDA Class 2 ·Orthopedic

EVA DIGITAL DENTAL X-RAY SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

RESORB-X SF

FDA 510(k)

FDA Class 2 ·Dental

EMPOWR PS Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

ENCORE ANTERIOR SPINAL STAPLE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic