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
11569–11592 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 01, 2004
3.5 MM LCP DISTAL HUMERUS SYSTEM
K033995 · KTT
Synthes (Usa)
Orthopedic · 68d
Cleared Mar 01, 2004
KOMPRESSOR SCREW SYSTEM
K040356 · HWC
Kinetikos Medical, Inc.
Orthopedic · 17d
Cleared Feb 27, 2004
EXACTECH RESORBABLE BONE PASTE
K020078 · MQV
Exactech, Inc.
Orthopedic · 779d
Cleared Feb 25, 2004
VERTEBRON PSS PEDICLE SCREW SYSTEM
K033352 · MNI
Vertebron, Inc.
Orthopedic · 128d
Cleared Feb 25, 2004
TRANSET FRACTURE FIXATION SYSTEM
K033717 · HTY
Bonutti Research, Inc.
Orthopedic · 91d
Cleared Feb 23, 2004
TITANIUM CANNULATED INTERFERENCE SCREW
K033749 · HWC
Advanced Biomaterials
Orthopedic · 84d
Cleared Feb 23, 2004
DEPUY SIGMA XLK TIBIAL INSERTS
K040166 · JWH
DePuy Orthopaedics, Inc.
Orthopedic · 28d
Cleared Feb 20, 2004
THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEM
K032064 · MQP
Theken Surgical,Llc
Orthopedic · 232d
Cleared Feb 20, 2004
STRYKER SPINE OASYS SYSTEM
K032394 · MNI
Howmedica Osteonics Corp.
Orthopedic · 200d
Cleared Feb 20, 2004
SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES
K033805 · LXT
Synthes (Usa)
Orthopedic · 74d
Cleared Feb 20, 2004
ACE PROXIMAL HUMERAL NAIL SYSTEM
K033806 · HSB
Depuy Ace
Orthopedic · 74d
Cleared Feb 20, 2004
ACE ANTEGRADE RETROGRADE HUMERAL NAIL SYSTEM
K033878 · HSB
Depuy Ace
Orthopedic · 67d
Cleared Feb 20, 2004
HANSSON PIN SYSTEM
K033968 · HTY
Howmedica Osteonics Corp.
Orthopedic · 60d
Cleared Feb 20, 2004
OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS
K040199 · JDQ
Osseus, LLC
Orthopedic · 22d
Cleared Feb 20, 2004
TRIGEN INTERTAN
K040212 · JDS
Smith & Nephew, Inc.
Orthopedic · 21d
Cleared Feb 18, 2004
CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT
K031859 · KWD
Arthrosurface, Inc.
Orthopedic · 247d
Cleared Feb 18, 2004
SPINAL CONCEPTS INC. CADENCE AND TRAXIS
K033517 · MQP
Spinal Concepts, Inc.
Orthopedic · 103d
Cleared Feb 18, 2004
VERTE-STACK SPINAL SYSTEM
K040167 · MQP
Medtronic Sofamor Danek
Orthopedic · 23d
Cleared Feb 13, 2004
EIUS UNICOMPARTMENTAL KNEE SYSTEM
K033769 · HSX
Howmedica Osteonics Corp.
Orthopedic · 72d
Cleared Feb 13, 2004
TITANIUM TOGGLE BUTTON(S)
K033838 · MBI
Biomet Manufacturing, Inc.
Orthopedic · 65d
Cleared Feb 13, 2004
OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED...
K033883 · JWH
Exactech, Inc.
Orthopedic · 60d
Cleared Feb 12, 2004
TITANIUM MESH SYSTEM
K032371 · MQP
Encore Medical, L.P.
Orthopedic · 195d
Cleared Feb 12, 2004
PRECISION SURGERY LIMITED VARIABLE AND FIXED CERVICAL PLATE SYSTEM
K032815 · KWQ
Precision Surgery Limited
Orthopedic · 156d
Cleared Feb 12, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K040072 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 29d