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
1945–1968 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 26, 2023
Global Modular Replacement System, Modular Replacement System, Modular...
K222056 · JDI
Howmedica Osteonics Corp., Dba...
Orthopedic · 198d
Cleared Jan 25, 2023
CREED™ Cannulated Screws
K223847 · HWC
Glw, Inc.
Orthopedic · 34d
Cleared Jan 25, 2023
OsteoCNX
K223563 · MQV
Converg Engineering
Orthopedic · 57d
Cleared Jan 25, 2023
Medline UNITE® Ankle Fusion Plating System
K222665 · HRS
Medline Industries, Inc.
Orthopedic · 141d
Cleared Jan 25, 2023
Advanced Bone Plate
K221150 · HRS
Double Medical Technology, Inc.
Orthopedic · 280d
Cleared Jan 23, 2023
CD Horizon Spinal System
K223494 · NKB
Medtronic
Orthopedic · 63d
Cleared Jan 21, 2023
OIC Variable Angle Small Fragment Locking Plate System
K223118 · HRS
Orthopaedic Implant Company
Orthopedic · 110d
Cleared Jan 20, 2023
GMK Sphere & GMK SpheriKA Cementless
K223548 · MBH
Medacta International S.A.
Orthopedic · 56d
Cleared Jan 20, 2023
Triathlon® Hinge Knee System
K223528 · KRO
Howmedica Osteonics Corp., Dba...
Orthopedic · 58d
Cleared Jan 20, 2023
ZESPIN SI Joint Fusion System
K223521 · OUR
Aegis Spine, Inc.
Orthopedic · 58d
Cleared Jan 20, 2023
Blueprint Mixed Reality system
K222510 · OLO
Tornier S.A.S.
Orthopedic · 154d
Cleared Jan 19, 2023
TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN...
K223108 · OLO
Medos International SARL
Orthopedic · 111d
Cleared Jan 19, 2023
EL CAPITAN Anterior Lumbar Interbody Fusion
K222554 · OVD
Astura Medical
Orthopedic · 149d
Cleared Jan 18, 2023
SI-Cure Sacroiliac Joint Fusion System
K223819 · OUR
Alevio, LLC
Orthopedic · 28d
Cleared Jan 18, 2023
Uni-FuZe-C Bone Strip
K221726 · MQV
Zavation Medical Products, LLC
Orthopedic · 218d
Cleared Jan 18, 2023
Anatomic Bone Plate
K221088 · HRS
Double Medical Technology, Inc.
Orthopedic · 280d
Cleared Jan 17, 2023
FairFix QT Adjustable Button
K223795 · MBI
Medacta International S.A.
Orthopedic · 29d
Cleared Jan 13, 2023
PathLoc-TA Expandable Lumbar Cage System
K223474 · MAX
L & K Biomed Co., Ltd.
Orthopedic · 56d
Cleared Jan 13, 2023
Galileo Vertebral Body Replacement Device
K221542 · PLR
Bright Spine
Orthopedic · 231d
Cleared Jan 13, 2023
SignaSure Dual Mobility System
K220495 · MEH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 325d
Cleared Jan 12, 2023
NuVasive Modulus-C Interbody System
K223731 · ODP
Nuvasive, Inc.
Orthopedic · 30d
Cleared Jan 11, 2023
INFINITY OCT System
K223764 · NKG
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 27d
Cleared Jan 11, 2023
Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System
K223719 · KWQ
Aegis Spine, Inc.
Orthopedic · 30d
Cleared Jan 11, 2023
NuVasive Reline System
K223181 · NKB
Nu Vasive, Incorporated
Orthopedic · 92d