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
10321–10344 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 19, 2006
FRS SCREW
K062352 · HWC
DePuy Orthopaedics, Inc.
Orthopedic · 69d
Cleared Oct 19, 2006
EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM
K062494 · HRS
Ebi, L.P.
Orthopedic · 55d
Cleared Oct 19, 2006
OSTEOPORE TCP
K062496 · MQV
Spinecraft, Inc.
Orthopedic · 55d
Cleared Oct 19, 2006
SYNTHES LCP DISTAL FEMUR PLATES
K062564 · HRS
Synthes (Usa)
Orthopedic · 49d
Cleared Oct 19, 2006
MODIFICATION TO LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM
K062831 · KWQ
Life Spine
Orthopedic · 29d
Cleared Oct 17, 2006
SOLITAIRE ANTERIOR SPINAL SYSTEM
K062810 · MQP
Ebi, L.P.
Orthopedic · 28d
Cleared Oct 13, 2006
DEPUY LPS PROXIMAL TIBIAL COMPONENT
K062301 · KRO
DePuy Orthopaedics, Inc.
Orthopedic · 66d
Cleared Oct 13, 2006
HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM
K062495 · MQV
Depuy Spine, Inc.
Orthopedic · 49d
Cleared Oct 13, 2006
NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED FLEX FIXED BEARING...
K062768 · JWH
Zimmer, Inc.
Orthopedic · 28d
Cleared Oct 11, 2006
TRIO + SPINAL SYSTEM
K062698 · MNI
Stryker Spine
Orthopedic · 30d
Cleared Oct 06, 2006
PASS 2 SPINAL SYSTEM
K062136 · MNI
Medicrea
Orthopedic · 72d
Cleared Oct 06, 2006
EBI ARAY SPINAL SYSTEM
K062685 · NKB
Ebi, L.P.
Orthopedic · 28d
Cleared Oct 05, 2006
KMI CEMENT RESTRICTOR IMPLANT
K061465 · JDK
Kinetikos Medical, Inc.
Orthopedic · 132d
Cleared Oct 05, 2006
UNIVERSAL SPINAL ANTERIOR LOCKING PLATE SYSTEM
K062686 · KWQ
Advanced Spine Technology, Inc.
Orthopedic · 27d
Cleared Oct 04, 2006
MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEM
K062617 · HWC
Inion , Ltd.
Orthopedic · 29d
Cleared Oct 03, 2006
SBI TRIHEDRON MTP HEMI GT
K062040 · KWD
Small Bone Innovations, Inc.
Orthopedic · 76d
Cleared Oct 03, 2006
SOLAR REUNION FRACTURE STEM
K062113 · KWS
Howmedica Osteonics Corp.
Orthopedic · 71d
Cleared Sep 29, 2006
DEPUY SIGMA CRUCIATE RETAINING POROCOAT FEMORAL COMPONENTS
K062654 · MBH
DePuy Orthopaedics, Inc.
Orthopedic · 22d
Cleared Sep 29, 2006
GLADIATOR BIPOLAR SYSTEM
K062693 · KWY
Wrightmedicaltechnologyinc
Orthopedic · 18d
Cleared Sep 29, 2006
ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MM
K062747 · HRS
Arthrex, Inc.
Orthopedic · 15d
Cleared Sep 27, 2006
ARTHREX CORKSCREW FT III SUTURE ANCHOR WITH THREE #2 SUTURES
K062679 · HWC
Arthrex, Inc.
Orthopedic · 19d
Cleared Sep 26, 2006
ISS INTEGRATED SPINE SYSTEM
K061524 · MNH
Ortho Development Corp.
Orthopedic · 116d
Cleared Sep 26, 2006
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K062133 · MQP
Medtronic Spinal and Biologics Div
Orthopedic · 62d
Cleared Sep 26, 2006
NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES
K062505 · MNI
Abbott Spine, Inc.
Orthopedic · 29d