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
5017–5040 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 11, 2017
CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the...
K170679 · NKB
Medtronic Sofamor Danek
Orthopedic · 66d
Cleared May 11, 2017
ANTHEM CR Total Knee System
K170648 · JWH
Smith & Nephew, Inc.
Orthopedic · 69d
Cleared May 11, 2017
Connector System
K170647 · NKG
Orthofix, Inc.
Orthopedic · 69d
Cleared May 11, 2017
Mako Partial Knee Application
K170584 · OLO
Mako Surgical Corp.
Orthopedic · 72d
Cleared May 11, 2017
Mako Total Knee Application
K170581 · OLO
Mako Surgical Corp.
Orthopedic · 72d
Cleared May 11, 2017
Arthrex Compression Screws
K170382 · HWC
Arthrex, Inc.
Orthopedic · 93d
Cleared May 10, 2017
MOJAVE Expandable Interbody System
K171097 · MAX
K2m, Inc.
Orthopedic · 27d
Cleared May 10, 2017
Orthofix TrueLok Hexapod System (TL-HEX) V2.0
K170650 · KTT
Orthofix Srl
Orthopedic · 68d
Cleared May 10, 2017
I.B.S. osteosynthesis screws
K170594 · HWC
In2bones Sas
Orthopedic · 71d
Cleared May 10, 2017
MALUC™ Total Hip Arthroplasty System
K162125 · JDI
Surgtech, Inc.
Orthopedic · 282d
Cleared May 09, 2017
Ocata Anterior Cervical System
K170342 · KWQ
Kalitec Direct, LLC
Orthopedic · 95d
Cleared May 08, 2017
VariAx 2 Foot System
K170771 · HRS
Stryker GmbH
Orthopedic · 55d
Cleared May 08, 2017
Rampart One Lumbar Interbody Fusion Device
K163670 · OVD
Spineology, Inc.
Orthopedic · 132d
Cleared May 08, 2017
Precifit Medical Kirschner Wires
K163327 · HTY
Precifit Medical, Ltd.
Orthopedic · 161d
Cleared May 05, 2017
Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS...
K171082 · NKB
Orthofix, Inc.
Orthopedic · 24d
Cleared May 05, 2017
SICAGE™ System
K170475 · OUR
Sicage, LLC
Orthopedic · 78d
Cleared May 05, 2017
Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor
K163672 · MAI
Nanova Biomaterials, Inc.
Orthopedic · 129d
Cleared May 05, 2017
Colink™ Plating System
K163293 · HRS
In2bones USA, LLC
Orthopedic · 164d
Cleared May 04, 2017
Arthrex SwiveLock Anchors
K171141 · MAI
Arthrex, Inc.
Orthopedic · 16d
Cleared May 04, 2017
VIPER PRIME™ Screws with Fenestrations
K170543 · NKB
Medos International SARL
Orthopedic · 69d
Cleared May 04, 2017
Foundation 3D Interbody
K162496 · ODP
Corelink, LLC
Orthopedic · 239d
Cleared May 03, 2017
SURESHOT Distal Targeting System V4.0 Trauma Interface
K170977 · OLO
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared May 03, 2017
KISSloc Suture System
K170440 · HTN
Arthrosurface, Inc.
Orthopedic · 78d
Cleared May 03, 2017
HALF DOME Posterior Lumbar Interbody System
K163481 · MAX
Astura Medical
Orthopedic · 142d