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
265–288 of 17,899
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 13, 2026
Hive™ Standalone Cervical System and Hive™ C Interbody System
K254105 · ODP
NanoHive Medical, LLC
Orthopedic · 56d
Cleared Feb 12, 2026
Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application
K253381 · OLO
Medtronic Navigation, Inc.
Orthopedic · 135d
Cleared Feb 12, 2026
Lumbar Spine Truss System - Plating Solution (LSTS-PS)
K253201 · KWQ
4Web, Inc.
Orthopedic · 139d
Cleared Feb 12, 2026
Wrist Fracture System
K251732 · HRS
Met One Technologies, LLC
Orthopedic · 251d
Cleared Feb 11, 2026
iFuse INTRA Ti™ Implant System
K253488 · OUR
SI-BONE, Inc.
Orthopedic · 110d
Cleared Feb 10, 2026
XT3 System
K260073 · JDW
Biodynamik, Inc.
Orthopedic · 32d
Cleared Feb 10, 2026
Vulcan Spinal System
K253545 · NKB
K2m, Inc.
Orthopedic · 88d
Cleared Feb 06, 2026
Q Interbody Instruments
K252873 · OLO
K2m, Inc.
Orthopedic · 149d
Cleared Feb 06, 2026
Spine Guidance 5.3 Software
K252871 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 149d
Cleared Feb 06, 2026
ROSA Knee System with UltraSound Imaging Platform (USIP)
K252058 · OLO
Balmoral Medical, LLC
Orthopedic · 220d
Cleared Feb 04, 2026
Signature™ ONE System
K260104 · QHE
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 22d
Cleared Feb 04, 2026
E3D™-C Interbody System
K260038 · OVE
Evolution Spine
Orthopedic · 29d
Cleared Feb 04, 2026
G7® Revision Acetabular System
K252623 · LPH
Zimmer, Inc.
Orthopedic · 169d
Cleared Feb 04, 2026
Luna® Ti Interbody Fusion System
K250773 · MAX
Spinal Elements, Inc.
Orthopedic · 327d
Cleared Feb 03, 2026
T2 Alpha Femur Retrograde Nailing System
K253640 · HSB
Stryker GmbH
Orthopedic · 76d
Cleared Feb 03, 2026
Navigation Module of the Cortium® System
K252087 · OLO
Ulrich Medical USA, Inc.
Orthopedic · 216d
Cleared Feb 03, 2026
MSS - Monobloc stem
K250644 · PHX
Medacta International S.A.
Orthopedic · 336d
Cleared Jan 29, 2026
Y-Knotless™ Flex Anchors
K253763 · MBI
Conmed Corporation
Orthopedic · 65d
Cleared Jan 29, 2026
Falco Fusion System
K253611 · OUR
Mcnicoll Surgical, Inc.
Orthopedic · 72d
Cleared Jan 28, 2026
Aevumed PROTEKT Suture Anchor
K260004 · MBI
Aevumed, Inc.
Orthopedic · 26d
Cleared Jan 28, 2026
Sacroiliac Joint Truss System (SJTS)
K252834 · OUR
4Web Medical
Orthopedic · 145d
Cleared Jan 28, 2026
XeliteMed SuperM-Fix Spinal Bone Cement
K251896 · NDN
Xelite Biomed , Ltd.
Orthopedic · 222d
Cleared Jan 28, 2026
Mpact 3D Metal Implants Extension – DMLS Technology
K251043 · LPH
Medacta International S.A.
Orthopedic · 300d
Cleared Jan 23, 2026
Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable...
K253748 · MAX
Life Spine, Inc.
Orthopedic · 59d