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
7681–7704 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Apr 13, 2012
ASCEND SHOULDER SYSTEM
K120794 · KWS
Tornier, Inc.
Orthopedic · 29d
Cleared Apr 11, 2012
TITAN MODULAR TOTAL SHOULDER SYSTEM
K112438 · KWS
Ascension Orthopedic
Orthopedic · 231d
Cleared Apr 10, 2012
MINI MAXLOCK EXTREME PLATING SYSTEM
K120157 · HRS
Orthohelix Surgical Designs, Inc.
Orthopedic · 83d
Cleared Apr 10, 2012
SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SET
K120390 · HWC
Solana Surgical, LLC
Orthopedic · 63d
Cleared Apr 09, 2012
FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT
K112481 · KXE
Ascension Orthopedic
Orthopedic · 224d
Cleared Apr 09, 2012
CAPSTONE CONTROL SPINAL SYSTEM
K120368 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 63d
Cleared Apr 06, 2012
CERVICAL PLATE
K113170 · KWQ
Eisertech, LLC
Orthopedic · 162d
Cleared Apr 06, 2012
NANOFUSE DBM
K120279 · MQV
Nanotherapeutics
Orthopedic · 67d
Cleared Apr 05, 2012
2GC HIP/KNEE MODULAR SPACER
K112470 · KWL
Mandell Horwitz Consultants, LLC
Orthopedic · 223d
Cleared Apr 05, 2012
CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM
K120570 · MQP
Choicespine, LP
Orthopedic · 38d
Cleared Apr 04, 2012
EVEREST SPINAL SYSTEM
K120656 · MNI
K2m, Inc.
Orthopedic · 30d
Cleared Apr 04, 2012
VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR...
K120667 · HRS
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Apr 03, 2012
SECURIS SPINAL FIXATION
K113361 · NKB
Cumtom Spine
Orthopedic · 141d
Cleared Apr 02, 2012
ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL )
K112982 · HSB
Small Bone Innovations, Inc.
Orthopedic · 179d
Cleared Apr 02, 2012
ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS...
K113829 · JWH
Materialise NV
Orthopedic · 97d
Cleared Apr 02, 2012
TIGER SPINE SYSTEM
K120696 · MNI
Corelink, LLC
Orthopedic · 26d
Cleared Apr 02, 2012
ORTHOLOC(TM) 3DI LOCKING SCREWS ORTHOLOC(TM) BONE SCREWS
K120802 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 17d
Cleared Mar 29, 2012
LOCKING COMPRESSION PLATE SYSTEM
K112798 · HRS
Shanghai Microport Orthopedics Co., Ltd.
Orthopedic · 184d
Cleared Mar 29, 2012
TIGER SPINE SYSTEM
K113058 · NKB
Corelink, LLC
Orthopedic · 167d
Cleared Mar 29, 2012
HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM
K113327 · KTT
Stryker Corp.
Orthopedic · 140d
Cleared Mar 29, 2012
ACCOLADE II HIP STEM
K120578 · JDI
Howmedica Osteonics
Orthopedic · 31d
Cleared Mar 28, 2012
REXIOUS HOOK FIXATION SYSTEMS
K113324 · KWP
Dio Medical Co., Ltd.
Orthopedic · 139d
Cleared Mar 28, 2012
ELLIPSE PRECICE TRAUMA NAIL SYSTEM
K113695 · HSB
Ellipse Technologies, Inc.
Orthopedic · 103d
Cleared Mar 28, 2012
ZAVATION IBF SYSTEM
K120576 · MAX
Zavation, LLC
Orthopedic · 30d