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
11497–11520 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 07, 2004
MODIFICATION TO EQUATION FIXATION SYSTEM
K042453 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared Oct 07, 2004
A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM
K042458 · LXT
A.M. Surgical, Inc.
Orthopedic · 27d
Cleared Oct 07, 2004
VERTEX RECONSTRUCTION SYSTEM
K042498 · KWP
Medtronic Sofamor Danek
Orthopedic · 23d
Cleared Oct 07, 2004
ORION ANTERIOR CERVICAL PLATING SYSTEM
K042499 · KWQ
Medtronic Sofamor Danek
Orthopedic · 23d
Cleared Oct 07, 2004
SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM
K042508 · KWP
Depuy Spine, Inc.
Orthopedic · 22d
Cleared Oct 07, 2004
MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM
K042514 · MNI
Blackstone Medical, Inc.
Orthopedic · 21d
Cleared Oct 05, 2004
AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR
K041698 · MAI
Axya Medical, Inc.
Orthopedic · 105d
Cleared Oct 05, 2004
ACUMED ANATOMIC RADIAL HEAD SYSTEM
K041858 · KWI
Acumed, LLC
Orthopedic · 88d
Cleared Oct 04, 2004
EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS
K040601 · KWZ
Exactech, Inc.
Orthopedic · 210d
Cleared Oct 01, 2004
EXACTECH OPTETRAK UNICONDYLAR KNEE
K040889 · HRY
Exactech, Inc.
Orthopedic · 179d
Cleared Oct 01, 2004
SYNTHES CONTOURED SYNMESH SPACER
K041389 · MQP
Synthes Spine
Orthopedic · 129d
Cleared Oct 01, 2004
ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
K041808 · KWP
Endius, Inc.
Orthopedic · 87d
Cleared Oct 01, 2004
M2A MAGNUM SYSTEM
K042037 · KWA
Biomet, Inc.
Orthopedic · 64d
Cleared Oct 01, 2004
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K042402 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Sep 30, 2004
TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ
K040630 · JWH
Implex Corp.
Orthopedic · 204d
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