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
865–888 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 29, 2025
Versalock Upper Limb Plating System
K243740 · HRS
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 56d
Cleared Jan 29, 2025
Xenco Medical CancelleX Cervical Interbody System
K243673 · ODP
Xenco Medical, LLC
Orthopedic · 63d
Cleared Jan 29, 2025
GYDER® Hip System
K243387 · OLO
Gyder Surgical Pty, Ltd.
Orthopedic · 90d
Cleared Jan 28, 2025
Argo Knotless GENESYS Anchor
K244025 · MBI
Conmed Corporation
Orthopedic · 32d
Cleared Jan 24, 2025
AxCess® Expandable Interbody System
K243739 · MAX
Elliquence, LLC
Orthopedic · 51d
Cleared Jan 23, 2025
ProLift Pivot Expandable Spacer System
K243668 · MAX
Life Spine, Inc.
Orthopedic · 57d
Cleared Jan 23, 2025
Acu-Sinch Knotless Mini
K243624 · HTN
Acumed, LLC
Orthopedic · 59d
Cleared Jan 23, 2025
OTS 25-L (100-5)
K241234 · MBI
Ots Medical , Ltd.
Orthopedic · 266d
Cleared Jan 22, 2025
EMPHASYS Acetabular System
K243977 · LPH
Depuy Ireland UC
Orthopedic · 30d
Cleared Jan 22, 2025
XT3 System
K241357 · JDW
Biodynamik, Inc.
Orthopedic · 253d
Cleared Jan 21, 2025
Precision AI Surgical Planning System (PAI-SPS)
K243955 · QHE
Precision AI Pty, Ltd.
Orthopedic · 29d
Cleared Jan 17, 2025
Mastergraft Matrix EXT
K243706 · MQV
Medtronic Sofamor Danek, Inc.
Orthopedic · 49d
Cleared Jan 17, 2025
TriALTIS™ Spine System
K243249 · NKB
Medos International SARL
Orthopedic · 98d
Cleared Jan 15, 2025
EffortMed Spinal Fixation System
K243946 · NKB
Effortmed, LLC
Orthopedic · 26d
Cleared Jan 15, 2025
TriMed Wrist Fixation System (Volar Bearing Plates)
K243569 · HRS
TriMed, Inc.
Orthopedic · 58d
Cleared Jan 14, 2025
Elegance® Anterior Cervical plate
K243904 · KWQ
Clariance
Orthopedic · 26d
Cleared Jan 14, 2025
Consensus Knee System with TiNbN
K241180 · JWH
Shalby Advanced Technologies
Orthopedic · 260d
Cleared Jan 13, 2025
ARVIS® Shoulder
K243950 · SBF
Kico Knee Innovation Company Pty, Ltd.
Orthopedic · 21d
Cleared Jan 13, 2025
Arthrex Intramedullary Nails
K243890 · HSB
Arthrex, Inc.
Orthopedic · 26d
Cleared Jan 13, 2025
Initia Knee System
K243295 · JWH
Kyocera Medical Technologies, Inc.
Orthopedic · 87d
Cleared Jan 13, 2025
Pantheon Proximal Femur Reconstruction (PFR) System
K241059 · LPH
Adler Ortho S.P.A
Orthopedic · 270d
Cleared Jan 10, 2025
NuVasive Pulse System
K243814 · OLO
Globus Medical, Inc.
Orthopedic · 30d
Cleared Jan 10, 2025
Universal Tendon Spacer
K243477 · HXA
Askorn Medical
Orthopedic · 63d
Cleared Jan 10, 2025
Arthrex SS VAL and VAL KreuLock™ Compression Screw System
K243195 · HWC
Arthrex, Inc.
Orthopedic · 101d