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
10441–10464 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 20, 2006
AEQUALIS REVERSED PROSTHESIS
K061439 · PHX
Tornier
Orthopedic · 57d
Cleared Jul 19, 2006
SBI ULNAR HEAD IMPLANT
K061146 · KXE
Small Bone Innovations, Inc.
Orthopedic · 85d
Cleared Jul 19, 2006
KFX KNOTLESS FIXATION SYSTEM
K061294 · MBI
Kfx Medical
Orthopedic · 71d
Cleared Jul 19, 2006
ALLTHREAD LACTOSORB SUTURE ANCHOR
K061389 · JDR
Arthrotek, Inc.
Orthopedic · 62d
Cleared Jul 18, 2006
ORTHOPEDIC SOURCE PRESS-FIT HIP
K061124 · LPH
Orthopedic Source, Inc.
Orthopedic · 85d
Cleared Jul 18, 2006
PCA 36MM FEMORAL HEADS
K061168 · LPH
Howmedica Osteonics Corp.
Orthopedic · 82d
Cleared Jul 18, 2006
CD HORIZON SPINAL SYSTEM
K061304 · NQP
Medtronic Sofamor Danek
Orthopedic · 69d
Cleared Jul 18, 2006
STORM OPERATING KIT, MODEL 1-10-0
K061607 · HTY
Intelligent Orthopaedics, Ltd.
Orthopedic · 39d
Cleared Jul 18, 2006
KALIX II IMPLANT
K061765 · HWC
New Deal, S.A.
Orthopedic · 26d
Cleared Jul 18, 2006
NUVASIVE SPHERX II SYSTEM
K061778 · MNH
Nuvasive, Inc.
Orthopedic · 22d
Cleared Jul 18, 2006
MODIFICATION TO ALLOMATRIX CUSTOM
K061939 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 8d
Cleared Jul 17, 2006
MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEM
K053624 · HRS
Medicon EG
Orthopedic · 201d
Cleared Jul 17, 2006
SMITH & NEPHEW MODULAR FEMORAL HEAD
K061243 · KWL
Smith & Nephew, Inc.
Orthopedic · 75d
Cleared Jul 17, 2006
FRAGMENT PLATE SYSTEM
K061748 · KTT
Hand Innovations, LLC
Orthopedic · 26d
Cleared Jul 17, 2006
DEPUY AML HIP PROSTHESIS
K061833 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 18d
Cleared Jul 14, 2006
OPUS LABRALOCK P KNOTLESS FIXATION DEVICE
K061349 · MBI
Arthrocare Corp.
Orthopedic · 60d
Cleared Jul 12, 2006
PATIENT MATCHED HIP STEM
K053246 · LZO
Smith & Nephew, Inc.
Orthopedic · 233d
Cleared Jul 12, 2006
NFIX FUSION SYSTEM
K053623 · MNH
N-Spine, Inc.
Orthopedic · 196d
Cleared Jul 12, 2006
PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS-TA
K060425 · NDN
Arthrocare Corp.
Orthopedic · 145d
Cleared Jul 12, 2006
MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR
K061698 · JDK
Life Spine
Orthopedic · 26d
Cleared Jul 11, 2006
COMPETITOR UNICONDYLAR KNEE TIBIAL BASEPLATE
K061011 · HSX
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Jul 10, 2006
SOLAR PUREFIX HA SHOULDER
K061677 · HSD
Howmedica Osteonics Corp.
Orthopedic · 25d
Cleared Jul 07, 2006
ZODIAC ADJUSTABLE BRIDGES, MODELS 11-20XX,11-25XX,11-30XX,11-35XX
K061321 · MNH
Alphatec Spine, Inc.
Orthopedic · 57d
Cleared Jul 07, 2006
APEX PINS
K061493 · JDW
Stryker Howmedica Osteonics
Orthopedic · 37d