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
9577–9600 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 29, 2008
CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM
K080860 · MQP
Creaspine
Orthopedic · 63d
Cleared May 29, 2008
INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD)
K081194 · OVE
Rsb Spine, LLC
Orthopedic · 31d
Cleared May 29, 2008
OMEGA 3 TROCHANTERIC STABILIZING PLATE
K081278 · KTT
Howmedica Osteonics Corp.
Orthopedic · 23d
Cleared May 28, 2008
REVERE UNIPLANAR SCREWS
K081195 · NKB
Globus Medical, Inc.
Orthopedic · 30d
Cleared May 23, 2008
ARCOFIX
K080020 · KWQ
Synthes Spine Co.Lp
Orthopedic · 141d
Cleared May 23, 2008
SYNTHES 3.5 MM LCP DISTAL TIBIA T PLATES
K080522 · HRS
Synthes (Usa)
Orthopedic · 87d
Cleared May 23, 2008
APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES]
K080842 · MBH
Omni Life Science, Inc.
Orthopedic · 59d
Cleared May 22, 2008
SPACER-G TEMPORARY HIP PROSTHESIS
K062273 · KWL
Tecres S.P.A.
Orthopedic · 654d
Cleared May 22, 2008
SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, SPK0121,...
K062274 · JWH
Tecres S.P.A.
Orthopedic · 654d
Cleared May 21, 2008
NOVEL SPINAL SPACER SYSTEM
K080699 · MQP
Alphatec Spine, Inc.
Orthopedic · 70d
Cleared May 21, 2008
CONQUEST SPINAL SYSTEM
K080767 · MNI
Life Spine
Orthopedic · 64d
Cleared May 16, 2008
MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM
K080029 · KRR
Mako Surgical Corp.
Orthopedic · 133d
Cleared May 15, 2008
ECHELON TITANIUM HIP SYSTEM
K072817 · LPH
Smith & Nephew, Inc.
Orthopedic · 226d
Cleared May 15, 2008
PEEK PREVAIL CERVICAL INTERBODY DEVICE
K073285 · OVE
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 174d
Cleared May 15, 2008
MODIFICATION TO VIPER SPINE SYSTEM
K073562 · NKB
Depuy Spine, Inc.
Orthopedic · 148d
Cleared May 15, 2008
PLATEAU SPACER SYSTEM
K080411 · MAX
Life Spine
Orthopedic · 90d
Cleared May 15, 2008
PROFEMUR LX 5/8 COATED HIP STEM
K081090 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 29d
Cleared May 14, 2008
SMARTSET MV BONE CEMENT
K081155 · LOD
DePuy Orthopaedics, Inc.
Orthopedic · 21d
Cleared May 14, 2008
SMARTSET GMV GENTAMICIN BONE CEMENT
K081163 · MBB
DePuy Orthopaedics, Inc.
Orthopedic · 20d
Cleared May 13, 2008
PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM
K073177 · MAX
Pioneer Surgical Technology
Orthopedic · 182d
Cleared May 13, 2008
OSTEOTRANS-OT PIN
K073311 · HTY
Takiron Co., Ltd.
Orthopedic · 172d
Cleared May 13, 2008
OSTEOTRANS-OT SCREW
K073312 · HWC
Takiron Co., Ltd.
Orthopedic · 172d
Cleared May 13, 2008
SPINAL USA INTERBODY FUSION DEVICE
K080314 · MAX
Spinal USA
Orthopedic · 97d
Cleared May 12, 2008
CONFORMIS TOTAL KNEE REPIAR SYSTEM (ITOTAL) TIBIAL COMPONENT: 6.0 MM THICKNESS
K080936 · JWH
Conformis, Inc.
Orthopedic · 40d