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
7729–7752 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 09, 2012
PICASSO MIS SPINAL FIXATION SYSTEM
K120714 · NKB
Accel Spine
Orthopedic · 154d
Cleared Aug 09, 2012
RENOIR POSTERIOR CERVIAL FIXATION SYSTEM
K121136 · KWP
Accel Spine
Orthopedic · 118d
Cleared Aug 09, 2012
PROFEMUR Z REVISION HIP STEM
K121221 · LZO
Wrightmedicaltechnologyinc
Orthopedic · 108d
Cleared Aug 08, 2012
REFORM PEDICLE SCREW SYSTEM
K121172 · MNI
Spinal USA
Orthopedic · 113d
Cleared Aug 07, 2012
NAUTILUS SPINAL SYSTEM
K111953 · NKB
Life Spine
Orthopedic · 393d
Cleared Aug 07, 2012
SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION
K121393 · MBH
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Aug 02, 2012
LANX SPINAL FIXATION SYSTEM
K121940 · NKB
Lanx, Inc.
Orthopedic · 31d
Cleared Jul 31, 2012
SYNTHES MATRIX SYSTEM
K120838 · NKB
Synthes Spine
Orthopedic · 133d
Cleared Jul 30, 2012
SPINAL ELEMENTS POSTERIOR CERVICAL/THORACIC SPINAL SYSTEM
K120467 · NKB
Spinal Elements, Inc.
Orthopedic · 166d
Cleared Jul 30, 2012
STERISPINEPS PEDICLE SCREW, STERISPINEPS ROD
K121299 · NKB
Safe Orthopaedics
Orthopedic · 91d
Cleared Jul 30, 2012
HIP SYSTEMS
K121308 · LPH
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Jul 30, 2012
DYNASTY BIOFOAM SHELL
K121544 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 66d
Cleared Jul 27, 2012
MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM
K121569 · ODP
Accel Spine
Orthopedic · 59d
Cleared Jul 27, 2012
VEGA KNEE SYSTEM
K121879 · JWH
Aesculap Implant Systems
Orthopedic · 29d
Cleared Jul 26, 2012
LDR SPINE USA AVENUE L INTERBODY FUSION
K113285 · OVD
Ldr Spine USA, Inc.
Orthopedic · 262d
Cleared Jul 26, 2012
PIONEER STERNAL ASSIST IMPLANT SYSTEM
K120016 · HRS
Pioneer Surgical Technology, Inc.
Orthopedic · 205d
Cleared Jul 26, 2012
STRYKER ALL SUTURE ANCHORS
K120509 · MBI
Stryker
Orthopedic · 156d
Cleared Jul 26, 2012
COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS
K121183 · PHX
Biomet Corporation
Orthopedic · 99d
Cleared Jul 26, 2012
BEACON STABILIZATION SYSTEM
K121922 · NKB
Globus Medical, Inc.
Orthopedic · 24d
Cleared Jul 26, 2012
SOVEREIGN SPINAL SYSTEM
K121982 · OVD
Medtronic Sofamor Danek
Orthopedic · 20d
Cleared Jul 25, 2012
HLS UNI EVOLUTION & U-KNEETEC
K120262 · HSX
Tornier, Inc.
Orthopedic · 180d
Cleared Jul 25, 2012
HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM
K121252 · KTT
Stryker Corp.
Orthopedic · 91d
Cleared Jul 25, 2012
SYNTHES ZERO-P VARIABLE ANGLE (VA)
K121852 · OVE
Synthes Spine Co.Lp
Orthopedic · 30d
Cleared Jul 20, 2012
SURGICASE CONNECT, SURGICASE GUIDE
K112389 · PBF
Materialise NV
Orthopedic · 337d