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
5065–5088 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Apr 24, 2017
Pantheon Medical Balanced Plating System
K162154 · HRS
Pantheon Medical
Orthopedic · 265d
Cleared Apr 21, 2017
Tomcat Cervical Spinal System
K170953 · OVE
Choicespine, LP
Orthopedic · 21d
Cleared Apr 20, 2017
Sniper Staple System
K162354 · JDR
Trilliant Surgical, Ltd.
Orthopedic · 240d
Cleared Apr 20, 2017
Ax Stand-Alone ALIF System
K162236 · OVD
Innovasis, Inc.
Orthopedic · 254d
Cleared Apr 19, 2017
GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System,...
K163383 · HRS
Greens Surgicals Pvt. , Ltd.
Orthopedic · 139d
Cleared Apr 18, 2017
Mako Total Hip Application
K170593 · OLO
Mako Surgical Corp.
Orthopedic · 49d
Cleared Apr 18, 2017
NovoGro
K162087 · MQV
Osteonovus, Inc.
Orthopedic · 264d
Cleared Apr 14, 2017
Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System
K170643 · MAX
Rti Surgical, Inc. Dba Rti Biologics
Orthopedic · 43d
Cleared Apr 14, 2017
Fortress™ Pedicular Fixation System
K170268 · NKB
Spineology, Inc.
Orthopedic · 77d
Cleared Apr 14, 2017
Palisade™ Pedicular Fixation System
K170266 · NKB
Spineology, Inc.
Orthopedic · 77d
Cleared Apr 14, 2017
Threshold™ V2 Pedicular Fixation System
K170255 · NKB
Spineology, Inc.
Orthopedic · 77d
Cleared Apr 14, 2017
Threshold™ Pedicular Fixation System
K170251 · NKB
Spineology, Inc.
Orthopedic · 77d
Cleared Apr 14, 2017
Hoffmann LRF System
K163656 · KTT
Stryker GmbH
Orthopedic · 112d
Cleared Apr 14, 2017
Navigated ELEVATE Inserter, Navigated Disc Prep Instruments
K163581 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 115d
Cleared Apr 14, 2017
GMK UNI
K161741 · HSX
Medacta International S.A.
Orthopedic · 294d
Cleared Apr 13, 2017
Additive Orthopaedics Locking Lattice Plate
K170214 · HRS
Additive Orthopaedics, LLC
Orthopedic · 79d
Cleared Apr 13, 2017
CAPRI Corpectomy Cage System
K170055 · MQP
K2m
Orthopedic · 97d
Cleared Apr 13, 2017
Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS...
K163269 · OVD
Titan Spine, LLC
Orthopedic · 143d
Cleared Apr 13, 2017
MICATM Screw System
K162353 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 233d
Cleared Apr 12, 2017
HIGH V+
K161114 · NDN
Teknimed Sas
Orthopedic · 357d
Cleared Apr 10, 2017
Keos Lumbar IBFD
K163386 · MAX
Keos
Orthopedic · 129d
Cleared Apr 10, 2017
ARROW Anatomical Porous glenoid
K162068 · MBF
Fournitures Hospitalieres Industrie
Orthopedic · 258d
Cleared Apr 07, 2017
ANTHEM™ Fracture System
K163361 · HRS
Globus Medical, Inc.
Orthopedic · 128d
Cleared Apr 07, 2017
Kepler II
K163265 · ODP
Orbbo Surgical, LLC
Orthopedic · 137d