TELIX K Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

PENN-PET SCANNER

FDA 510(k)

FDA Class 2 ·Radiology

Chronos®

FDA 510(k)

FDA Class 2 ·General Hospital

MOSS VRS Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

MOSS 100 Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

ABBOTT AXSYM 3RD GENERATION TSH ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AIA-PACK TSH 3RD-GEN ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT

FDA 510(k)

FDA Class 2 ·Immunology

KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT

FDA 510(k)

FDA Class 2 ·Immunology

Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker

FDA 510(k)

FDA Class 2 ·Neurology

Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece

FDA 510(k)

FDA Class 2 ·Neurology

BRYAN SPINAL FIXATER (BSF)

FDA 510(k)

FDA Class 2 ·Orthopedic

Spine Guidance Software, Stryker Q Guidance System

FDA 510(k)

FDA Class 2 ·Neurology

Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap

FDA 510(k)

FDA Class 2 ·Neurology

COMPACT SPACER

FDA 510(k)

FDA Class 2 ·Anesthesiology

TRILOGY TX WITH 3RD PARTY COUCH TOP SUPPORT

FDA 510(k)

FDA Class 2 ·Radiology

THE DAVIS DISPOSABLE PROTECTIVE SPLINT

FDA 510(k)

FDA Class 2 ·Neurology

Neocis Planning Software Application (NPSA) for 3rd Party PCs

FDA 510(k)

FDA Class 2 ·Dental