FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: OLO ×
439 results
313–336 of 439
Search insights Median review: 97d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
Cleared Jun 29, 2018
NuVasive Pulse System
K180038 · OLO
Nu Vasive, Incorporated
Orthopedic · 175d
Cleared Jun 25, 2018
Navigation Instruments
K180690 · OLO
Globus Medical, Inc.
Orthopedic · 101d
Cleared May 17, 2018
Navigated INFINITY Instruments
K181111 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 20d
Cleared May 11, 2018
SeaSpine Navigation System
K172517 · OLO
SeaSpine Orthopedics Corporation
Orthopedic · 263d
Cleared May 02, 2018
ADAPT for Gamma3
K173946 · OLO
Stryker GmbH
Orthopedic · 126d
Cleared May 02, 2018
7D Surgical System
K180352 · OLO
7D Surgical, Inc.
Orthopedic · 83d
Cleared May 02, 2018
Spineology Navigation Instruments
K180796 · OLO
Spineology, Inc.
Orthopedic · 36d
Cleared Apr 30, 2018
Mazor X
K180307 · OLO
Mazor Robotics , Ltd.
Orthopedic · 87d
Cleared Apr 27, 2018
OLYMPIC Navigated Instruments
K172166 · OLO
Astura Medical
Orthopedic · 283d
Cleared Apr 24, 2018
Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter
K180277 · OLO
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared Apr 06, 2018
NAVIO™ Surgical System (NAVIO system)
K180271 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 65d
Cleared Mar 08, 2018
Navigated Instrument System
K172115 · OLO
Orthofix, Inc.
Orthopedic · 238d
Cleared Jan 18, 2018
Navigated INFINITY™ Instruments
K173338 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 87d
Cleared Jan 16, 2018
K2M Navigation Instruments
K171556 · OLO
K2m
Orthopedic · 231d
Cleared Jan 05, 2018
Spineology Navigation Instruments
K172518 · OLO
Spineology, Inc.
Orthopedic · 137d
Cleared Dec 21, 2017
NuVasive Navigation Instruments
K172623 · OLO
Nu Vasive, Incorporated
Orthopedic · 111d
Cleared Nov 24, 2017
ExactechGPS Total Shoulder Application
K173372 · OLO
Blue Ortho
Orthopedic · 28d
Cleared Nov 22, 2017
OrthAlign Plus System
K172462 · OLO
Orthalign, Inc.
Orthopedic · 100d
Cleared Nov 16, 2017
Intellijoint HIP System (Cart), Intellijoint HIP System (Portable),...
K172849 · OLO
Intellijoint Surgical, Inc.
Orthopedic · 57d
Cleared Nov 02, 2017
Mako Partial Knee Application
K172301 · OLO
Mako Surgical Corp.
Orthopedic · 94d
Cleared Oct 31, 2017
iFuse Implant System- iFuse Navigation
K172268 · OLO
SI-BONE, Inc.
Orthopedic · 96d
Cleared Oct 30, 2017
Intellijoint HIP Generation 2B System
K171525 · OLO
Intellijoint Surgical, Inc.
Orthopedic · 158d
Cleared Oct 18, 2017
Stryker Spine Navigation System with SpineMap 3D software application,...
K172034 · OLO
Stryker Corporation
Orthopedic · 105d
Cleared Sep 21, 2017
Mako Total Knee Application
K172219 · OLO
Mako Surgical Corp.
Orthopedic · 59d