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
6313–6336 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 09, 2015
NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM
K141253 · MNI
New Era Orthopaedics, LLC
Orthopedic · 240d
Cleared Jan 09, 2015
SPINOUS PROCESS FUSION (SPF) PLATE
K140046 · PEK
Spinal Simplicity, LLC
Orthopedic · 366d
Cleared Jan 08, 2015
SIDEKICK EZ FRAME External Fixation System
K143220 · KTT
Wrightmedicaltechnologyinc
Orthopedic · 59d
Cleared Jan 08, 2015
CONSTRUX MINI PEEK
K142152 · ODP
Orthofix, Inc.
Orthopedic · 155d
Cleared Jan 08, 2015
CrossTie Intraosseous Fixation System
K141857 · HWC
Orthodiscovery Group, LLC (D.B.A....
Orthopedic · 182d
Cleared Jan 07, 2015
MAXIMIS SPINAL FIXATION SYSTEM
K140359 · MNH
Valorem Surgical
Orthopedic · 329d
Cleared Jan 05, 2015
Arsenal Spinal Fixation System
K143149 · NKB
Alphatec Spine, Inc.
Orthopedic · 63d
Cleared Jan 02, 2015
FIREBIRD SPINAL FIXATION SYSTEM
K141186 · NKB
Orthofix, Inc.
Orthopedic · 240d
Cleared Dec 31, 2014
LITe Plate System
K142699 · KWQ
Stryker Corporation
Orthopedic · 100d
Cleared Dec 30, 2014
3.Omm Biomet Cannulated Screw System
K143188 · HWC
Biomet Manufacturing Corp
Orthopedic · 55d
Cleared Dec 30, 2014
ACROSSPINE PEDICLE SCREW SYSTEM
K141695 · NKB
Arthro-Dif
Orthopedic · 189d
Cleared Dec 29, 2014
G7 Finned Acetabular Shell
K142746 · LPH
Biomet Manufactuting Corp.
Orthopedic · 96d
Cleared Dec 29, 2014
VECTRIX EXTERNAL FIXATOR
K140649 · NDK
3D Medical Concepts, LLC
Orthopedic · 291d
Cleared Dec 23, 2014
Klassic HD Hip System
K143407 · LZO
Total Joint Othopedics, Inc.
Orthopedic · 25d
Cleared Dec 23, 2014
Biomet Tibial trays
K142933 · JWH
Biomet, Inc.
Orthopedic · 75d
Cleared Dec 23, 2014
ALIANS ULNA LOCKING PLATING SYSTEM
K142502 · HRS
Newclip Technics
Orthopedic · 109d
Cleared Dec 23, 2014
nvc
K142328 · ODP
Nvision Biomedical Technologies, LLC
Orthopedic · 125d
Cleared Dec 23, 2014
Wrist Hemiarthroplasty System
K141920 · KWN
Arthrosurface, Inc.
Orthopedic · 160d
Cleared Dec 22, 2014
AxSOS 3 Ti Locking Plate System
K143138 · HRS
Stryker Trauma AG
Orthopedic · 49d
Cleared Dec 22, 2014
ANTHEM PS Total Knee System
K142807 · JWH
Smith & Nephew, Inc.
Orthopedic · 84d
Cleared Dec 22, 2014
Zimmer Persona Personalized Knee System
K142787 · JWH
Zimmer, Inc.
Orthopedic · 87d
Cleared Dec 22, 2014
Caspian OCT/MESA Mini/DENALI Mini Spinal System
K142558 · KWP
K2m
Orthopedic · 102d
Cleared Dec 22, 2014
AnthroBridge-Screw 25,30,35,40,45,50mm
K142528 · HWC
Agent Medical, LLC
Orthopedic · 104d
Cleared Dec 19, 2014
Reform Pedicle Screw System
K143248 · NKB
Precision Spine, Inc.
Orthopedic · 37d