FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,766 results
2809–2832 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 29, 2020
ARIX Ankle Distal Tibia System
K202912 · HRS
Jeil Medical Corporation
Orthopedic · 30d
Cleared Oct 29, 2020
ANTHEM Fracture System
K202496 · HRS
Globus Medical, Inc.
Orthopedic · 59d
Cleared Oct 29, 2020
NuVasive Modulus XLIF Interbody System
K201692 · MAX
Nu Vasive, Incorporated
Orthopedic · 129d
Cleared Oct 29, 2020
EXPERT - Joint Fixation System
K200332 · HTN
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 262d
Cleared Oct 29, 2020
Libertas E-XLPE Modular Liner
K192989 · OQI
Maxx Orthopedics, Inc.
Orthopedic · 370d
Cleared Oct 28, 2020
Syntec Femoral Nail Extended System
K202935 · HSB
Syntec Scientific Corporation
Orthopedic · 29d
Cleared Oct 28, 2020
Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ...
K202259 · MBI
Parcus Medical, LLC
Orthopedic · 79d
Cleared Oct 28, 2020
EVOS Cabling System
K201497 · JDQ
Pioneer Surgical Technology, Inc....
Orthopedic · 145d
Cleared Oct 28, 2020
LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System
K200790 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 216d
Cleared Oct 28, 2020
Comprehensive Shoulder System
K193038 · MBF
Biomet Manufacturing Corp
Orthopedic · 363d
Cleared Oct 27, 2020
Triathlon PKR System
K203099 · HSX
Howmedica Osteonics Corp. A.K.A....
Orthopedic · 13d
Cleared Oct 27, 2020
Mazor X
K203005 · OLO
Mazor Robotics , Ltd.
Orthopedic · 26d
Cleared Oct 27, 2020
IlluminOss Bone Stabilization System
K202887 · QAD
Illuminoss Medical, Inc.
Orthopedic · 29d
Cleared Oct 27, 2020
NextAR TKA Platform
K202152 · SBF
Medacta International S.A.
Orthopedic · 85d
Cleared Oct 26, 2020
Cannulated Power Driver Attachment
K202528 · NKB
K2m, Inc.
Orthopedic · 55d
Cleared Oct 26, 2020
AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System
K202489 · HRS
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 56d
Cleared Oct 26, 2020
DOLOMITE Anterior Cervical Stabilization System
K202065 · OVE
Astura Medical, LLC
Orthopedic · 91d
Cleared Oct 26, 2020
ACURA Stabilization System
K200937 · NKB
Indius Medical Technologies Pvt. , Ltd.
Orthopedic · 201d
Cleared Oct 23, 2020
Wiltrom Spinal Fixation System
K202894 · NKB
Wiltrom Corporation Limited
Orthopedic · 25d
Cleared Oct 23, 2020
Mobio Total Knee System
K202429 · JWH
B-One Ortho, Corp.
Orthopedic · 59d
Cleared Oct 22, 2020
GEO Bone Screw System
K202817 · HWC
Gramercy Extremity Orthopedics, LLC
Orthopedic · 28d
Cleared Oct 21, 2020
ACTIS Duofix Hip Prosthesis
K202472 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 54d
Cleared Oct 21, 2020
Trivergent Spinal Fixation System
K201427 · NKB
Benvenue Medical, Inc.
Orthopedic · 145d
Cleared Oct 21, 2020
PRO-DENSE LoVisc Bone Graft Substitute
K200507 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 233d