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
8041–8064 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 29, 2011
INQU PASTE MIX PLUS
K103799 · MQV
Isto Technologies, Inc.
Orthopedic · 244d
Cleared Aug 29, 2011
NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK),...
K111572 · LZO
Serf
Orthopedic · 84d
Cleared Aug 29, 2011
SLIC SCREW REPAIR SYSTEM
K111608 · HWC
Acumed, LLC
Orthopedic · 81d
Cleared Aug 26, 2011
INSTINCT JAVA SYSTEM
K111301 · NKB
Zimmer Spine
Orthopedic · 109d
Cleared Aug 25, 2011
DAYTONA ANTERIOR CERVICAL CAGE
K110733 · ODP
Spinenet, LLC
Orthopedic · 162d
Cleared Aug 24, 2011
CHESAPEAKE (CERVICAL COMPONENTS)
K111439 · OVE
K2m, Inc.
Orthopedic · 92d
Cleared Aug 24, 2011
PERIMETER INTERBODY FUSION DEVICE
K111525 · MAX
Medtronic Sofamor Danek
Orthopedic · 84d
Cleared Aug 24, 2011
PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES
K111528 · KWQ
Pioneer Surgical Technology, Inc.
Orthopedic · 83d
Cleared Aug 23, 2011
PASS ANTERIOR SPINAL SYSTEM
K102406 · KWQ
Medicrea Technologies
Orthopedic · 364d
Cleared Aug 23, 2011
STREAMLINE TL SPINAL SYSTEM
K111502 · NKB
Pioneer Surgical Technology, Inc.
Orthopedic · 84d
Cleared Aug 23, 2011
SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE...
K111620 · HRS
Skeletal Dynamics, LLC
Orthopedic · 74d
Cleared Aug 22, 2011
TALON DISTALFIX PROXIMAL FEMORAL NAIL
K111352 · HSB
Orthopedic Designs North America, Inc.
Orthopedic · 101d
Cleared Aug 19, 2011
STAXX XDL SYSTEM
K102315 · MQP
Spine Wave, Inc.
Orthopedic · 368d
Cleared Aug 19, 2011
TRIMED RADIOCARPAL FUSION SYSTEM
K102785 · HRS
TriMed, Inc.
Orthopedic · 326d
Cleared Aug 19, 2011
BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR
K110879 · MBI
Biomet Sports Medicine
Orthopedic · 142d
Cleared Aug 19, 2011
EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R) TRIAD (TM) BONE SCREWS
K111432 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 88d
Cleared Aug 19, 2011
SONOMA FASTRAC CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA FASTRAC...
K111550 · HSB
Sonoma Orthopedic Products, Inc.
Orthopedic · 77d
Cleared Aug 19, 2011
ARTHREX SCAPHOLUNATE ANCHOR
K111661 · MBI
Arthrex, Inc.
Orthopedic · 66d
Cleared Aug 19, 2011
PROFEMUR(R) E CEMENTLESS HIP STEM
K111698 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 63d
Cleared Aug 19, 2011
PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM
K111699 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 63d
Cleared Aug 19, 2011
NUGAIT(TM) SUBTALAR IMPLANT SYSTEM
K111799 · HWC
Ascension Orthopedic
Orthopedic · 53d
Cleared Aug 19, 2011
POLARIS SPINAL SYSTEM
K111957 · NKB
Biomet Spine (Ebi, LLC)
Orthopedic · 39d
Cleared Aug 19, 2011
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K112108 · MNI
Spineart
Orthopedic · 28d
Cleared Aug 18, 2011
SMR REVERSE SHOULDER SYSTEM
K110598 · PHX
Lima Corporate S.P.A.
Orthopedic · 169d