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
9625–9648 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Apr 28, 2008
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION
K080885 · JDI
Medacta International S.A.
Orthopedic · 28d
Cleared Apr 25, 2008
EXTERNAL FIXATION CLAMP 5.0 MM PIN X9.5MM ROD, MODEL 1151-100, EXTERNAL...
K080408 · KTT
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 71d
Cleared Apr 25, 2008
MANTA RAY ANTERIOR CERVICAL PLATE SYSTEM
K080690 · KWQ
Theken Spine, LLC
Orthopedic · 45d
Cleared Apr 24, 2008
CAPSTONE SPINAL SYSTEM
K073291 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 153d
Cleared Apr 24, 2008
FOUNDATION CAGE
K073440 · MAX
Corelink, LLC
Orthopedic · 139d
Cleared Apr 23, 2008
TORNIER CINCH KNOTLESS FIXATION IMPLANT SYSTEM
K080335 · MBI
Tornier, Inc.
Orthopedic · 76d
Cleared Apr 23, 2008
PLLA, HA SCREW
K080358 · HWC
Smith & Nephew Inc., Endoscopy Div.
Orthopedic · 72d
Cleared Apr 23, 2008
TOSCA II ANTERIOR CERVICAL PLATE SYSTEM
K080815 · KWQ
Signus Medizintechnik GmbH
Orthopedic · 30d
Cleared Apr 23, 2008
SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS
K080943 · HWC
Synthes (Usa)
Orthopedic · 20d
Cleared Apr 21, 2008
REGENEREX TIBIAL COMPONENTS
K080361 · MBH
Biomet, Inc.
Orthopedic · 70d
Cleared Apr 21, 2008
PLEXUR-P
K080511 · MQV
Osteotech, Inc.
Orthopedic · 56d
Cleared Apr 18, 2008
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K080805 · KWP
Medtronic Sofamor Danek
Orthopedic · 28d
Cleared Apr 17, 2008
ISOBAR SEMI-RIGID DUAL DAMPENER
K071261 · NQP
Scient'X
Orthopedic · 349d
Cleared Apr 17, 2008
SIERRA
K072729 · KWP
Seaspine, Inc.
Orthopedic · 204d
Cleared Apr 16, 2008
TURBO PRIME IBD SYSTEM
K080058 · MAX
Spineselect, LLC
Orthopedic · 98d
Cleared Apr 16, 2008
SIERRA SYSTEM
K080526 · KWP
Seaspine, Inc.
Orthopedic · 50d
Cleared Apr 16, 2008
ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE
K080736 · MQV
Apatech , Ltd.
Orthopedic · 30d
Cleared Apr 15, 2008
COMPORUS
K062691 · MQV
Takiron Co., Ltd.
Orthopedic · 582d
Cleared Apr 10, 2008
INTREPID SPINAL SYSTEM
K080083 · MAX
Medtronic Sofamor Danek
Orthopedic · 90d
Cleared Apr 10, 2008
INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW
K080434 · JDO
Smith & Nephew, Inc.
Orthopedic · 51d
Cleared Apr 10, 2008
DARCO HEADLESS COMPRESSION SCREW
K080850 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 15d
Cleared Apr 09, 2008
PASS SPINAL SYSTEM
K080099 · MNI
Medicrea Technologies
Orthopedic · 86d
Cleared Apr 08, 2008
MODIFICATION TO:PILOT SPINAL SYSTEM
K080502 · MNI
Life Spine
Orthopedic · 43d
Cleared Apr 08, 2008
PROFEMUR LX REVISION 5/8 COATED HIP STEM
K080663 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 29d