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
9745–9768 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 25, 2008
BIOSET XCH
K072238 · MQV
Regeneration Technologies, Inc.
Orthopedic · 165d
Cleared Jan 25, 2008
STALIF (TM) C
K072415 · OVE
Surgicraft , Ltd.
Orthopedic · 150d
Cleared Jan 25, 2008
BENGAL STACKABLE CAGE SYSTEM
K073649 · MQP
Depuy Spine, Inc.
Orthopedic · 30d
Cleared Jan 24, 2008
DSS
K072969 · NQP
Paradigm Spine, LLC
Orthopedic · 94d
Cleared Jan 24, 2008
LANX INTERVERTEBRAL BODY FUSION DEVICE
K073144 · MAX
Lanx, LLC
Orthopedic · 78d
Cleared Jan 24, 2008
CRYSTAL
K073351 · ODP
Spinal Elements, Inc.
Orthopedic · 56d
Cleared Jan 24, 2008
DEPUY SIGMA PS FEMORAL COMPONENTS
K073529 · JWH
DePuy Orthopaedics, Inc.
Orthopedic · 38d
Cleared Jan 24, 2008
BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR
K073654 · KWP
Blackstone Medical, Inc.
Orthopedic · 29d
Cleared Jan 24, 2008
ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01
K080024 · MQP
K2m, Inc.
Orthopedic · 20d
Cleared Jan 18, 2008
PATRIOT SPACERS
K072970 · MAX
Globus Medical, Inc.
Orthopedic · 88d
Cleared Jan 18, 2008
PATRIOT SPACERS: COLONIAL ACDF
K072991 · ODP
Globus Medical, Inc.
Orthopedic · 87d
Cleared Jan 17, 2008
ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANT
K071456 · MAI
Arthrex, Inc.
Orthopedic · 237d
Cleared Jan 17, 2008
GRYPHON BR AND HEALIX BR ANCHORS
K073412 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 44d
Cleared Jan 16, 2008
CHAMELEON FIXATION SYSTEM
K071420 · MRW
Spinefrontier, Inc.
Orthopedic · 239d
Cleared Jan 14, 2008
INNERVUE DIAGNOSTIC SCOPE SYSTEM
K072879 · HRX
Biomet Orthopedics, Inc.
Orthopedic · 97d
Cleared Jan 11, 2008
TRANS1 AXIAL FIXATON SYSTEM
K073514 · KWQ
Trans1 Incorporated
Orthopedic · 28d
Cleared Jan 10, 2008
SMITH & NEPHEW MIS HIP STEM
K072417 · LPH
Smith & Nephew, Inc.
Orthopedic · 135d
Cleared Jan 10, 2008
SYNTHES OC FUSION AND SYNAPSE SYSTEMS
K072434 · MNI
Synthes Spine Co.Lp
Orthopedic · 134d
Cleared Jan 10, 2008
PIONEER SLIMFUSE ANTERIOR CERVICAL PLATING SYSTEM
K072703 · KWQ
Pioneer Surgical Technology
Orthopedic · 108d
Cleared Jan 10, 2008
REVELATION AND LINEAR HIP STEMS AND FMP ACETABULAR SHELLS (SPIKED,...
K072888 · LPH
Encore Medical, L.P.
Orthopedic · 92d
Cleared Jan 10, 2008
ACCIN HIP SYSTEM
K073068 · LPH
Accelerated Innovation, LLC
Orthopedic · 72d
Cleared Jan 09, 2008
PROGENIX DMB PUTTY
K072265 · MQV
Medtronic Sofamor Danek
Orthopedic · 147d
Cleared Jan 09, 2008
REPIPHYSIS LIMB SALVAGE PROXIMAL FEMUR AND TOTAL FEMUR
K072367 · KRO
Wrightmedicaltechnologyinc
Orthopedic · 139d
Cleared Jan 09, 2008
F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE
K072432 · JEC
Hand Biomechanics Lab, Inc.
Orthopedic · 133d