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
3721–3744 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 28, 2019
Conformis BeneFIT Hip System
K190904 · LPH
Conformis, Inc.
Orthopedic · 142d
Cleared Aug 28, 2019
Signature Ceramic Femoral Head
K190704 · LZO
Signature Orthopaedics Pty, Ltd.
Orthopedic · 163d
Cleared Aug 26, 2019
Navigated T2 STRATOSPHERE Inserters and Navigated Templates
K191039 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 129d
Cleared Aug 23, 2019
Rampart™ One Lumbar Interbody Fusion System
K192047 · OVD
Spineology, Inc.
Orthopedic · 23d
Cleared Aug 23, 2019
REMEDY Acetabular Cup
K191981 · KWL
Osteoremedies, LLC
Orthopedic · 30d
Cleared Aug 23, 2019
VariAx 2 System, VariAx 2 Mini Fragment System
K191412 · HRS
Stryker GmbH
Orthopedic · 87d
Cleared Aug 23, 2019
Libertas – Taper Uncemented Femoral Stem
K183684 · LZO
Maxx Orthopedics, Inc.
Orthopedic · 238d
Cleared Aug 22, 2019
NCB Polyaxial Locking Plate System
K192021 · HRS
Zimmer GmbH
Orthopedic · 24d
Cleared Aug 22, 2019
INFINITY Total Ankle System, INBONE Total Ankle System
K191393 · HSN
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Aug 22, 2019
HEALIX ADVANCE SP BIOCOMPOSITE Anchor
K191242 · MAI
Medos International SARL
Orthopedic · 105d
Cleared Aug 22, 2019
Triathlon Total Knee System-Additional Components
K190402 · JWH
Stryker Orthopaedics (Aka Howmedica...
Orthopedic · 184d
Cleared Aug 21, 2019
VSP Orthopedics System
K190044 · PBF
3D Systems, Inc.
Orthopedic · 224d
Cleared Aug 20, 2019
iNSitu Total Hip System
K191936 · LPH
Thecken Companies, LLC
Orthopedic · 32d
Cleared Aug 20, 2019
Exactech Equinoxe Humeral Augmented Trays
K191561 · PHX
Exactech, Inc.
Orthopedic · 68d
Cleared Aug 19, 2019
CrossRoads Screw System
K191342 · HWC
Crossroads Extemity Systems, LLC
Orthopedic · 91d
Cleared Aug 19, 2019
Zavation eZspand Interbody System
K191339 · MAX
Zavation Medical Products, LLC
Orthopedic · 91d
Cleared Aug 16, 2019
Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS...
K192018 · ODP
Titan Spine, Inc.
Orthopedic · 18d
Cleared Aug 16, 2019
APTUS Foot System
K191636 · JDR
Medartis AG
Orthopedic · 58d
Cleared Aug 16, 2019
TriMAX Implant System
K190722 · JDR
Crossroads Extemity Systems, LLC
Orthopedic · 149d
Cleared Aug 15, 2019
ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical...
K191621 · ODP
Choice Spine, LLC
Orthopedic · 58d
Cleared Aug 15, 2019
Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal...
K190991 · MBH
Howmedica Osteonics Corp. (Aka...
Orthopedic · 122d
Cleared Aug 14, 2019
NuVaisve® Reline® Cervical System
K191553 · NKG
Nu Vasive, Incorporated
Orthopedic · 63d
Cleared Aug 14, 2019
AutoStrut
K191241 · KTT
Orthospin
Orthopedic · 98d
Cleared Aug 14, 2019
BOSS Toe Fixation System
K190261 · KWD
Arthrosurface, Inc.
Orthopedic · 187d