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
1417–1440 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 21, 2023
Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System
K233423 · HRS
Tyber Medical, LLC
Orthopedic · 72d
Cleared Dec 21, 2023
Cannulated Screw System
K233396 · HWC
Smith & Nephew, Inc.
Orthopedic · 79d
Cleared Dec 21, 2023
SkyOPS™ Orthopedic Plate System
K233154 · HRS
Sky Surgical, LLC
Orthopedic · 85d
Cleared Dec 21, 2023
SMR Hybrid Glenoid System
K231099 · MBF
Lima Corporate S.P.A.
Orthopedic · 247d
Cleared Dec 20, 2023
Peridot-PT Anterior Cervical Intervertebral body fusion System
K233839 · ODP
Gbs Commonwealth Co., Ltd.
Orthopedic · 16d
Cleared Dec 20, 2023
TM Plating System
K233017 · HRS
Tyber Medical, LLC
Orthopedic · 89d
Cleared Dec 20, 2023
Tactoset® Injectable Bone Substitute
K231968 · MQV
Anika Therapeutics, Inc.
Orthopedic · 170d
Cleared Dec 20, 2023
SPECTRUM® GV Bone Cement
K231556 · LOD
Osteoremedies, LLC
Orthopedic · 204d
Cleared Dec 20, 2023
United Orthopedic Knee Patient Specific Instrumentation
K230850 · OOG
Enhatch, Inc.
Orthopedic · 267d
Cleared Dec 20, 2023
MagnetOs Putty
K230736 · MQV
Kuros Biosciences B.V
Orthopedic · 278d
Cleared Dec 19, 2023
CORAIL Cemented Femoral Stem
K231526 · KWY
Depuy Ireland UC
Orthopedic · 207d
Cleared Dec 19, 2023
PMT Facet Fixation System, Lumbar (PMT FFS-LX)
K230840 · MRW
Providence Medical Technology, Inc.
Orthopedic · 267d
Cleared Dec 18, 2023
CC-Clip® Implant System
K232780 · HTN
Cc-Instruments, Inc.
Orthopedic · 98d
Cleared Dec 15, 2023
MagnetOs Easypack Putty
K233607 · MQV
Kuros Biosciences B.V
Orthopedic · 36d
Cleared Dec 15, 2023
Internal Locking Plate and Screw Fixation System
K232394 · HRS
Changzhou Geasure Medical Apparatus...
Orthopedic · 128d
Cleared Dec 15, 2023
Precice Max System
K232267 · HSB
Nuvasive Specialized Orthopedics,...
Orthopedic · 137d
Cleared Dec 15, 2023
Double Internal Joint Stabilizer- Elbow
K231447 · OZI
Skeletal Dynamics, Inc.
Orthopedic · 211d
Cleared Dec 14, 2023
Ascension Silicone MCP
K233670 · KYJ
Ascension Orthopedics, Inc.
Orthopedic · 29d
Cleared Dec 14, 2023
VELYS™ Robotic-Assisted Solution
K233227 · OLO
Depuy Ireland UC
Orthopedic · 77d
Cleared Dec 14, 2023
ARIX Ankle Distal Tibia System
K231887 · HRS
Jeil Medical Corporation
Orthopedic · 170d
Cleared Dec 13, 2023
Genesys Spine 3DP AIS-C II Cervical Interbody System
K233594 · OVE
Genesys Spine
Orthopedic · 35d
Cleared Dec 13, 2023
FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex...
K232877 · MRW
K&J Consulting Corporation
Orthopedic · 89d
Cleared Dec 13, 2023
Anatomical Plating System (various)
K232652 · HRS
Tyber Medical, LLC
Orthopedic · 104d
Cleared Dec 13, 2023
Kalitec Navigated Instrument System
K232572 · OLO
Kalitec Direct, LLC Doing Business AS...
Orthopedic · 111d