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
3097–3120 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Apr 29, 2020
M-Vizion Femoral Revision System Extension
K191816 · LZO
Medacta International S.A.
Orthopedic · 299d
Cleared Apr 28, 2020
Solstice CCI
K200896 · NKG
Life Spine, Inc.
Orthopedic · 25d
Cleared Apr 28, 2020
Tiger® Occipital-Cervical-Thoracic Spinal Fixation System
K200863 · NKG
Corelink, LLC
Orthopedic · 27d
Cleared Apr 28, 2020
Affixus(R) Natural Nail(R) System Humeral Nail
K200814 · HSB
Zimmer GmbH
Orthopedic · 29d
Cleared Apr 28, 2020
Hive™ Stand-alone Anterior Lumbar Interbody System
K200541 · OVD
Hd Lifesciences, LLC
Orthopedic · 56d
Cleared Apr 25, 2020
PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar
K200007 · LZO
Microport Orthopedics, Inc.
Orthopedic · 114d
Cleared Apr 24, 2020
Smith&Nephew VISIONAIRE Patient Matched Cutting Blocks
K200826 · JWH
Smith & Nephew, Inc.
Orthopedic · 25d
Cleared Apr 24, 2020
EXPEDIUM® Spine System
K200245 · NKB
Medos International S?rl
Orthopedic · 84d
Cleared Apr 24, 2020
SeaSpine Reef TH System
K193636 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 119d
Cleared Apr 24, 2020
SPIRA-C Integrated Fixation System
K193153 · OVE
Camber Spine Technologies
Orthopedic · 163d
Cleared Apr 23, 2020
CoLink Cfx Plating System
K200762 · HRS
In2bones USA, LLC
Orthopedic · 30d
Cleared Apr 23, 2020
Stryker Xia 3 Power Adaptor
K200666 · NKB
Stryker Spine
Orthopedic · 41d
Cleared Apr 23, 2020
ARx Spinal System
K200070 · NKB
Life Spine, Inc.
Orthopedic · 101d
Cleared Apr 23, 2020
DynaClip Bone Staple
K193305 · JDR
MedShape, Inc.
Orthopedic · 146d
Cleared Apr 22, 2020
DB-Orthopedics
K200752 · MQV
Dimensional Bioceramics, LLC
Orthopedic · 30d
Cleared Apr 21, 2020
EL CAPITAN Anterior Lumber Interbody System
K192492 · OVD
Astura Medical, LLC
Orthopedic · 223d
Cleared Apr 21, 2020
Galileo Vertebral Body Replacement Device
K192145 · PLR
Bright Spine
Orthopedic · 257d
Cleared Apr 20, 2020
MOTO PFJ System
K200122 · KRR
Medacta International S.A.
Orthopedic · 90d
Cleared Apr 18, 2020
S4 Screw System
K191995 · HWC
Subchondral Solutions, Inc.
Orthopedic · 267d
Cleared Apr 17, 2020
SI-Restore Sacroiliac Joint Fixation System
K200868 · OUR
Biofusion Medical
Orthopedic · 16d
Cleared Apr 17, 2020
Kyocera Bipolar Hip System
K200709 · KWY
Kyocera Medical Technologies, Inc.
Orthopedic · 30d
Cleared Apr 17, 2020
ProLift Lateral Fixated
K200338 · OVD
Life Spine, Inc.
Orthopedic · 66d
Cleared Apr 16, 2020
HydroCision SpineJet System
K200729 · HRX
Hydrocision, Inc.
Orthopedic · 27d
Cleared Apr 16, 2020
SIGMA High Performance (HP) Partial Knee System
K193549 · HRY
Depuy Ireland UC
Orthopedic · 118d