FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,899 results
121–144 of 17,899
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 12, 2026
OSTEOMNI SPINAL CAGES SYSTEM
K260850 · ODP
OSTEOMNI, Inc.
Orthopedic · 57d
Cleared May 12, 2026
VersaLift Expandable System
K260837 · MAX
Life Spine, Inc.
Orthopedic · 60d
Cleared May 11, 2026
Pytheas Your Guided Trajectory
K252880 · OLO
Pytheas Navigation Sas
Orthopedic · 243d
Cleared May 09, 2026
Avanti Distal Elbow ORIF System
K261145 · HRS
Avanti Orthopaedics, LLC
Orthopedic · 32d
Cleared May 09, 2026
aprevo® anterior and lateral lumbar interbody system
K260385 · MAX
Carlsmed, Inc.
Orthopedic · 92d
Cleared May 08, 2026
Arthrex Beaming System
K254215 · HWC
Arthrex, Inc.
Orthopedic · 130d
Cleared May 08, 2026
Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA
K253991 · HSB
Orthofix Srl
Orthopedic · 147d
Cleared May 07, 2026
Veritas Reverse Total Shoulder System
K253992 · PHX
Restor3d
Orthopedic · 146d
Cleared May 07, 2026
SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System,...
K253739 · NKB
Globus Medical, Inc.
Orthopedic · 164d
Cleared May 06, 2026
CastleLoc-P Anterior Cervical Plate System
K261112 · KWQ
L & K Biomed Co., Ltd.
Orthopedic · 33d
Cleared May 06, 2026
Anchor with Fiber Wire and Disposable Inserter
K253027 · MBI
Ortobio S.A.
Orthopedic · 229d
Cleared May 05, 2026
AccelFix Spinal Fixation System
K261130 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 29d
Cleared May 05, 2026
MectaLIF 3D Metal Anterior
K254202 · OVD
Medacta International S.A.
Orthopedic · 127d
Cleared May 01, 2026
FX V135 EASYTECH® Shoulder System
K254154 · PKC
FX Shoulder Solutions, Inc.
Orthopedic · 130d
Cleared May 01, 2026
OSSIOfiber® Threaded Trimmable Fixation Nail
K254077 · HWC
OSSIO , Ltd.
Orthopedic · 134d
Cleared May 01, 2026
PERLA® TL Posterior Thoraco-lumbar Fixation System
K253966 · NKB
Spineart SA
Orthopedic · 141d
Cleared May 01, 2026
Oxiplex
K253326 · QVL
Fziomed, Inc.
Orthopedic · 213d
Cleared May 01, 2026
ArthroTAK Tendon Anchor Kit
K252635 · MBI
ArthroTAK, LLC
Orthopedic · 254d
Cleared Apr 30, 2026
BEE PLIF Cage
K261067 · MAX
NGMedical GmbH
Orthopedic · 29d
Cleared Apr 30, 2026
OrthoPediatrics® Locking Cannulated Blade Plate System
K260323 · HRS
OrthoPediatrics Corp.
Orthopedic · 90d
Cleared Apr 29, 2026
SCRIPT™ Implant System
K253401 · MAX
Globus Medical, Inc.
Orthopedic · 211d
Cleared Apr 29, 2026
LEO Spinal System
K252542 · NKB
ZheJiang Decans Medical Devices Co.,...
Orthopedic · 260d
Cleared Apr 28, 2026
M.U.S.T. Pedicle Screw System - Extension
K253940 · NKB
Medacta International S.A.
Orthopedic · 140d
Cleared Apr 27, 2026
NovoKnee (SteriKnee)
K261032 · JWH
NovoSource
Orthopedic · 28d