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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,850 results
11377–11400 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Sep 30, 2004
SHOULDER FIXATION SYSTEM
K042059 · LXT
Hand Innovations, Inc.
Orthopedic · 62d
Cleared Sep 24, 2004
ST360 SPINAL FIXATION SYSTEM
K041925 · KWP
Zimmer Spine, Inc.
Orthopedic · 67d
Cleared Sep 24, 2004
HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
K042019 · KTT
Howmedica Osteonics Corp.
Orthopedic · 59d
Cleared Sep 24, 2004
JET-X BAR CLAMPS AND PIN CLAMPS-NON-MAGNETIC/MR SAFE
K042312 · KTT
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Sep 24, 2004
CERVICAL PLATE
K042317 · KWQ
Scient'X
Orthopedic · 29d
Cleared Sep 23, 2004
SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS
K041591 · JWH
Howmedica Osteonics Corp.
Orthopedic · 101d
Cleared Sep 23, 2004
MODIFICATION TO VBR SPINAL SYSTEM
K041722 · MQP
Depuy Spine, Inc.
Orthopedic · 91d
Cleared Sep 21, 2004
ARTELON SPACER CMC-1
K040070 · KYI
Artimplant AB
Orthopedic · 251d
Cleared Sep 20, 2004
BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR
K042100 · MNI
Blackstone Medical, Inc.
Orthopedic · 47d
Cleared Sep 20, 2004
BONE FUSION PLATE SYSTEM
K042205 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 35d
Cleared Sep 17, 2004
ORION ANTERIOR CERVICAL PLATING SYSTEM
K042235 · KWQ
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Sep 16, 2004
CORAL SPINAL SYSTEM
K041592 · KWP
Theken Surgical
Orthopedic · 94d
Cleared Sep 16, 2004
ALLOMATRIX TCP, ALLOMATRIX W/CASO4 FILLED TCP, AND ALLOMATRIX PLUS CBM
K041663 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Sep 16, 2004
SINTEA BIOTECH ANTERIOR PLATE SYSTEM, MODEL ACP.XX.T5.X
K041989 · KWQ
Sintea Biotech, Inc.
Orthopedic · 55d
Cleared Sep 16, 2004
HYPROCURE SUBTALAR IMPLANT SYSTEM
K042030 · HWC
Graham Medical Technologies, LLC
Orthopedic · 50d
Cleared Sep 16, 2004
EBI PERIARTICULAR PLATING SYSTEM
K042237 · HRS
Ebi, L.P.
Orthopedic · 29d
Cleared Sep 16, 2004
BONE-LOK MVP CORTICAL-CANCELLOUS COMPRESSION DEVICE
K042244 · HWC
Triage Medical, Inc.
Orthopedic · 28d
Cleared Sep 16, 2004
SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020
K042295 · HWC
Linvatec Biomaterials, Ltd.
Orthopedic · 23d
Cleared Sep 16, 2004
ORTHO-PRO CANNULATED BONE SCREWS
K042310 · HWC
Ortho-Pro, LLC
Orthopedic · 22d
Cleared Sep 15, 2004
EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED
K033634 · KWA
Centerpulse Orthopedics, Inc.
Orthopedic · 301d
Cleared Sep 15, 2004
CD HORIZON SPINAL SYSTEM
K041862 · KWP
Medtronic Sofamor Danek
Orthopedic · 68d
Cleared Sep 15, 2004
CLS SPOTORNO STEM
K042249 · LZO
Zimmer Austin, Inc.
Orthopedic · 27d
Cleared Sep 14, 2004
TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION...
K041771 · LXC
Twin Star Medical, Inc.
Orthopedic · 76d
Cleared Sep 10, 2004
EXACTECH 12/14 TOTAL HIP SYSTEM
K041906 · LPH
Exactech, Inc.
Orthopedic · 57d