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
49–72 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Sep 03, 2026
Tempo Plating System
K261647 · HRS
Pace Surgical
Orthopedic · 107d
Cleared Sep 02, 2026
ArthroTAK Tendon Anchor Kit
K262809 · MBI
ArthroTAK, LLC
Orthopedic · 26d
Cleared Sep 02, 2026
Momentum Acetabular Cup System
K253948 · LZO
United Orthopedic Corporation
Orthopedic · 266d
Cleared Sep 02, 2026
Aevumed SUPERCYNCH™ Button System
K253065 · MBI
Aevumed, Inc.
Orthopedic · 345d
Cleared Sep 01, 2026
Arthrex DynaNite Staples
K262451 · JDR
Arthrex, Inc.
Orthopedic · 46d
Cleared Sep 01, 2026
SK Knee System
K253961 · JWH
Just Medical Devices (Tianjin) Co., Ltd.
Orthopedic · 265d
Cleared Aug 28, 2026
Primal K-Wire (P99-193-1410)
K262722 · HTY
Paragon 28, Inc.
Orthopedic · 28d
Cleared Aug 28, 2026
FRAXION 3.5 Plate System (Various - See Catalog)
K261830 · HRS
Ortler Global Tibbi Gerecler Anonim...
Orthopedic · 87d
Cleared Aug 28, 2026
Fule Vertebroplasty Balloon Catheter
K260203 · HRX
Beijing Fule Science & Technology...
Orthopedic · 217d
Cleared Aug 28, 2026
Mpact 3D Metal Foam
K253630 · LPH
Medacta International S.A.
Orthopedic · 282d
Cleared Aug 27, 2026
Iconix Knotless T
K262677 · MBI
Riverpoint Medical
Orthopedic · 28d
Cleared Aug 26, 2026
VariLift-C Cervical Interbody Fusion System
K262595 · ODP
Wenzel Spine, Inc.
Orthopedic · 30d
Cleared Aug 26, 2026
GraftGun Universal Graft Delivery System (GDS®)
K262581 · FMF
SurGenTec, LLC
Orthopedic · 30d
Cleared Aug 26, 2026
HOPKINS Telescopes for Arthroscopy
K254103 · HRX
Karl Storz SE & CO. KG
Orthopedic · 250d
Cleared Aug 24, 2026
TiLink-L™ SI Joint Fusion System
K261381 · OUR
SurGenTec, LLC
Orthopedic · 119d
Cleared Aug 24, 2026
OsteoCoil™ GT Active Compression System
K260106 · HWC
Flower Orthopedics Corporation DBA...
Orthopedic · 222d
Cleared Aug 24, 2026
Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments
K253515 · JDI
Biomet Orthopedics, Inc.
Orthopedic · 290d
Cleared Aug 21, 2026
Pisces-SC Standalone Cervical Interbody System
K261882 · OVE
Osseus Fusions Systems, LLC
Orthopedic · 77d
Cleared Aug 21, 2026
EVOLUTION® AM BIOFOAM® Tibial System
K253728 · MBH
Microport Orthopedics, Inc.
Orthopedic · 270d
Not Cleared Aug 21, 2026
ReneuRx™ (Neural Ice)
DEN250067 · SJA
Brixton Biosciences
Orthopedic · 249d
Cleared Aug 20, 2026
Remex Spine Surgery Navigation - Universal Instruments
K262506 · OLO
Remex Medical Corp.
Orthopedic · 30d
Cleared Aug 20, 2026
SCALA® TL
K261049 · MAX
Spineart SA
Orthopedic · 142d
Cleared Aug 19, 2026
Versalock Sterile Plating System
K262537 · HRS
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 27d
Cleared Aug 18, 2026
TeKBrace Solo Soft Tissue Reinforcement Device
K262729 · QUW
Theramicro
Orthopedic · 18d