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
13105–13128 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 30, 2000
COLORADO II SPINAL SYSTEM
K984360 · MNH
Sofamor Danek USA,Inc.
Orthopedic · 479d
Cleared Mar 29, 2000
SINGLE SIZE TENDON SPACER
K000019 · HXA
Medist International
Orthopedic · 85d
Cleared Mar 29, 2000
SYNTHES ANTERIOR CSLP SYSTEM
K000742 · KWQ
Synthes Spine
Orthopedic · 22d
Cleared Mar 24, 2000
ORTHO DEVELOPMENT BALANCED KNEE SYSTEM
K994370 · JWH
Ortho Development Corp.
Orthopedic · 88d
Cleared Mar 23, 2000
PINNACLE ACETABULAR SYSTEM
K000306 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 51d
Cleared Mar 23, 2000
SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828
K000616 · MAI
Bionx Implants, Ltd.
Orthopedic · 28d
Cleared Mar 16, 2000
TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM
K994366 · MEH
Howmedica Osteonics Corp.
Orthopedic · 80d
Cleared Mar 15, 2000
SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM
K000066 · HRS
Synthes (Usa)
Orthopedic · 65d
Cleared Mar 15, 2000
SYNTHES ANTERIOR CSLP SYSTEM
K000536 · KWQ
Synthes Spine
Orthopedic · 28d
Cleared Mar 15, 2000
MALLORY/HEAD LATERALIZED PRESS-FIT FEMORAL
K000538 · LPH
Biomet, Inc.
Orthopedic · 27d
Cleared Mar 15, 2000
CENTAUR SPINAL SYSTEM
K994347 · KWQ
Howmedica Osteonics Corp.
Orthopedic · 83d
Cleared Mar 15, 2000
SYNTHES BUTTON PLATE
K994364 · MBI
Synthes (Usa)
Orthopedic · 79d
Cleared Mar 13, 2000
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
K994207 · KRO
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Mar 10, 2000
SPIRAL RADIUS RODDING SYSTEM
K000009 · KWQ
United States Surgical, A Division of...
Orthopedic · 67d
Cleared Mar 10, 2000
DURACON SYMMETRIC METAL-BACKED PATELLAR COMPONENT
K000091 · JWH
Howmedica Osteonics Corp.
Orthopedic · 57d
Cleared Mar 10, 2000
MODIFICATION TO SYNTHES USS
K000450 · MNI
Synthes Spine
Orthopedic · 28d
Cleared Mar 10, 2000
MODIFICATION TO CD SPINAL SYSTEM
K000453 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Mar 10, 2000
MODIFICATION TO CD SPINAL SYSTEM
K000476 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 25d
Cleared Mar 10, 2000
GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD
K000575 · KWS
DePuy Orthopaedics, Inc.
Orthopedic · 17d
Cleared Mar 10, 2000
ROD TO ROD CROSS BRACES
K000634 · KWQ
Corin USA
Orthopedic · 14d
Cleared Mar 10, 2000
MAGELLAN TIBIAL INTRAMEDULLARY NAIL
K992850 · HSB
Orthomatrix, Inc.
Orthopedic · 199d
Cleared Mar 10, 2000
MAGELLAN HUMERAL INTRAMEDULLARY NAIL
K992856 · HSB
Orthomatrix, Inc.
Orthopedic · 199d
Cleared Mar 10, 2000
INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS
K993259 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 163d
Cleared Mar 10, 2000
ZMR HIP SYSTEM-POROUS REVISION
K994286 · LPH
Zimmer, Inc.
Orthopedic · 81d