FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Orthopedic ×
17,985 results
4561–4584 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 06, 2018
SeaSpine Mariner Pedicle Screw System
K173882 · NKB
SeaSpine Orthopedics Corporation
Orthopedic · 47d
Cleared Feb 02, 2018
Triathlon Total Knee System
K173849 · MBH
Stryker Orthopaedics
Orthopedic · 45d
Cleared Feb 02, 2018
Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage
K173800 · MQP
Camber Spine Technologies
Orthopedic · 50d
Cleared Feb 02, 2018
Materialise TKA Guide System
K173445 · JWH
Materialise NV
Orthopedic · 88d
Cleared Feb 02, 2018
Bicera Resorbable Bone Substitute
K172237 · MQV
Wiltrom Corporation Limited
Orthopedic · 192d
Cleared Feb 02, 2018
The Plateau-LO Spacer System
K172105 · MAX
Life Spine, Inc.
Orthopedic · 205d
Cleared Feb 01, 2018
The Solstice OCT System
K173047 · NKG
Life Spine, Inc.
Orthopedic · 126d
Cleared Feb 01, 2018
Double Medical Cage System
K172828 · MAX
Double Medical Technology, Inc.
Orthopedic · 136d
Cleared Feb 01, 2018
ABCcolla Bone Graft
K171629 · MQV
Acro Biomedical Co., Ltd.
Orthopedic · 244d
Cleared Jan 30, 2018
Zimmer Persona Personalized Knee System
K173417 · MBH
Zimmer, Inc.
Orthopedic · 90d
Cleared Jan 29, 2018
DeGen Medical E3 MIS Pedicle Screw System
K173814 · NKB
Degen Medical
Orthopedic · 45d
Cleared Jan 29, 2018
40-42mm BiPolar Head and 22mm Femoral Head
K163081 · KWY
Signature Orthopaedics Pty, Ltd.
Orthopedic · 452d
Cleared Jan 26, 2018
TiGer Shark™ System
K172816 · MAX
Choicespine, LP
Orthopedic · 130d
Cleared Jan 25, 2018
Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS...
K172116 · HRX
Stryker Corporation
Orthopedic · 196d
Cleared Jan 24, 2018
SeaSpine Cabo ACP (Anterior Cervical Plate) System
K173521 · KWQ
SeaSpine Orthopedics Corporation
Orthopedic · 71d
Cleared Jan 23, 2018
ARROW Reverse Porous Glenoid
K171789 · PHX
Fournitures Hospitalieres Industrie
Orthopedic · 222d
Cleared Jan 22, 2018
Centurion POCT System
K180025 · NKG
Orthofix, Inc.
Orthopedic · 19d
Cleared Jan 22, 2018
EZ Plate
K173306 · KWQ
Zavation Medical Products, LLC
Orthopedic · 96d
Cleared Jan 22, 2018
FortiCore®
K171312 · MAX
Nanovis, LLC
Orthopedic · 263d
Cleared Jan 19, 2018
GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert
K173875 · JWH
Stelkast, Inc.
Orthopedic · 29d
Cleared Jan 19, 2018
DIP Arthrodesis System
K173616 · HTY
In2bones Sas
Orthopedic · 58d
Cleared Jan 19, 2018
BioSphere MIS Putty (BioSphere MIS)
K173301 · MQV
Synergy Biomedical, LLC
Orthopedic · 94d
Cleared Jan 19, 2018
Reliance Lumbar IBF System
K173283 · MAX
Reliance Medical Systems, LLC
Orthopedic · 95d
Cleared Jan 19, 2018
Choice Spine Laminoplasty™ Fixation System
K173215 · NQW
Choicespine, LP
Orthopedic · 109d