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
10777–10800 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 21, 2005
MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM
K052734 · KWP
Medtronic Sofamor Danek
Orthopedic · 21d
Cleared Oct 21, 2005
CONCORDE VBR SPINAL SYSTEM
K052746 · MQP
Depuy Spine, Inc.
Orthopedic · 21d
Cleared Oct 17, 2005
TECTONIC CERVICAL PLATE SYSTEM
K051531 · KWQ
K2m, LLC
Orthopedic · 130d
Cleared Oct 17, 2005
MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM
K051815 · KWQ
Vertebron, Inc.
Orthopedic · 104d
Cleared Oct 17, 2005
PROVEN REVISION MODULAR TIBIAL TRAY
K051976 · JWH
Stelkast Company
Orthopedic · 88d
Cleared Oct 17, 2005
3.8MM CS FACET COMPRESSION DEVICE
K052043 · MRW
Triage Medical, Inc.
Orthopedic · 81d
Cleared Oct 17, 2005
OLECRANONPLATE WITH ANGULAR STABILITY
K052368 · HRS
I.T.S. Implantat-Technologie-Systeme...
Orthopedic · 49d
Cleared Oct 17, 2005
FRAGMENT SPECIFIC FIXATOR
K052498 · KTT
David J. Slutsky MD
Orthopedic · 35d
Cleared Oct 17, 2005
ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)
K052630 · HWC
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 21d
Cleared Oct 13, 2005
HYBRID ANTERIOR CERVICAL PLATE SYSTEM
K052552 · KWQ
Depuy Spine, Inc.
Orthopedic · 27d
Cleared Oct 12, 2005
NV CORMED SOLAS SPINAL SYSTEM
K051959 · MNH
Nv Cormed
Orthopedic · 86d
Cleared Oct 12, 2005
SCORPIO KNEE SYSTEM TIBIAL INSERTS AND PATELLAR COMPONENTS
K051977 · JWH
Howmedica Osteonics Corp.
Orthopedic · 83d
Cleared Oct 12, 2005
SYNTHES UNIVERSAL LOCKING TROCHANTER STABILIZATION PLATE (ULTSP)
K052677 · HRS
Synthes (Usa)
Orthopedic · 14d
Cleared Oct 11, 2005
UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS
K050373 · HSX
Arthrosurface, Inc.
Orthopedic · 239d
Cleared Oct 11, 2005
MODIFICATION TO: XIA 4.5 SPINAL SYSTEM
K052761 · MNI
Stryker Spine
Orthopedic · 11d
Cleared Oct 07, 2005
EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE
K050997 · MQP
Flexuspine, Inc.
Orthopedic · 170d
Cleared Oct 07, 2005
ARCTEC SEMIRIGID PLATING SYSTEM
K051044 · MNH
Altiva Corp.
Orthopedic · 165d
Cleared Oct 07, 2005
NOVASPINE CEMENT RESTRICTOR NSCR
K051607 · JDK
Novaspine, LLC
Orthopedic · 112d
Cleared Oct 07, 2005
EQUATOR PLUS ACETABULAR CUP SYSTEM
K051844 · MAY
Portland Orthopaedics Pty. , Ltd.
Orthopedic · 92d
Cleared Oct 07, 2005
MODIFICATION TO: VERTE-STACK SPINAL SYSTEM
K052261 · MQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 49d
Cleared Oct 07, 2005
LANX VBR SYSTEM
K052384 · MQP
Lanx, LLC
Orthopedic · 38d
Cleared Oct 07, 2005
SYNTHES LCP PROXIMAL TIBIA PLATES LINE EXTENSION
K052390 · HRS
Synthes (Usa)
Orthopedic · 37d
Cleared Oct 07, 2005
AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR
K052491 · MBI
Axya Medical, Inc.
Orthopedic · 25d
Cleared Oct 07, 2005
S-BONE HIP TOOL
K052538 · HRS
Orthopedic Sciences, Inc.
Orthopedic · 22d