FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,766 results
11161–11184 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 07, 2005
SOLAR 2 ANATOMIC SHOULDER
K040432 · HSD
Stryker Orthopaedics
Orthopedic · 323d
Cleared Jan 07, 2005
X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM
K041824 · HRX
Future Medical Systems, SA
Orthopedic · 185d
Cleared Jan 07, 2005
GLAXY 3.2 SPINAL SYSTEM
K043020 · KWP
Medtronic Sofamor Danek
Orthopedic · 65d
Cleared Jan 07, 2005
SYNTHES (USA) CHRONOS
K043045 · MQV
Synthes (Usa)
Orthopedic · 64d
Cleared Jan 07, 2005
BF+
K043347 · MQV
Ldr Spine USA
Orthopedic · 32d
Cleared Jan 07, 2005
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K043566 · MQP
Medtronic Sofamor Danek
Orthopedic · 11d
Cleared Jan 05, 2005
SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM
K043310 · HWE
Synthes (Usa)
Orthopedic · 35d
Cleared Dec 29, 2004
TITANIUM MESH IMPLANT
K041407 · MQP
Interpore Cross Intl.
Orthopedic · 216d
Cleared Dec 29, 2004
FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5
K042713 · MQP
Spine Next America Corporation
Orthopedic · 90d
Cleared Dec 29, 2004
FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 1, 2, 3 AND 4
K042714 · MQP
Spine Next America Corporation
Orthopedic · 96d
Cleared Dec 29, 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K043561 · MQP
Medtronic Sofamor Danek
Orthopedic · 2d
Cleared Dec 28, 2004
SPACEVISION CAGE SYSTEM
K042930 · MQP
Spine Vision, Inc.
Orthopedic · 67d
Cleared Dec 28, 2004
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K043343 · MNH
Medtronic Sofamor Danek
Orthopedic · 22d
Cleared Dec 28, 2004
CEMEX SYSTEM GENTA FAST BONE CEMENT
K043403 · LOD
Exactech, Inc.
Orthopedic · 18d
Cleared Dec 27, 2004
HERBERT ULNAR HEAD PROSTHESIS SYSTEM
K042902 · KXE
Stuckenbrock Medizintechnik GmbH
Orthopedic · 68d
Cleared Dec 27, 2004
CEMENTEK LV
K042911 · MQV
Teknimed, S.A.
Orthopedic · 67d
Cleared Dec 27, 2004
PARALLAX ACRYLIC RESIN WITH TRACERS, MODEL KP-PAR-003
K042947 · NDN
Arthrocare Corp.
Orthopedic · 62d
Cleared Dec 27, 2004
MODIFICATION TO T2 PROXIMAL HUMERAL NAIL
K043404 · HSB
Howmedica Osteonics Corp.
Orthopedic · 17d
Cleared Dec 22, 2004
DEPUY C-STEM AMT HIP PROSTHESIS
K042959 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 56d
Cleared Dec 21, 2004
TRABECULAR METAL KNEE SYSTEM AUGMENTS
K040487 · MBH
Implex Corp.
Orthopedic · 300d
Cleared Dec 21, 2004
MEDALLION MODULAR HIP SYSTEM
K041850 · LPH
Biomet Manufacturing, Inc.
Orthopedic · 166d
Cleared Dec 21, 2004
APEX K2 HIP SYSTEM
K041950 · LPH
Apex Surgical, LLC
Orthopedic · 154d
Cleared Dec 21, 2004
VERTEX RECONSTRUCTION SYSTEM
K042789 · KWP
Medtronic Sofamor Danek
Orthopedic · 76d
Cleared Dec 21, 2004
M2A/C2A ACETABULAR SYSTEM
K042841 · JDL
Biomet, Inc.
Orthopedic · 68d