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
11137–11160 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 26, 2005
CHARLOTTE SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003
K043583 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 29d
Cleared Jan 25, 2005
Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED
K040685 · LWJ
Osteoimplant Technology, Inc.
Orthopedic · 315d
Cleared Jan 25, 2005
EQUESTRA FLUID DELIVERY SYSTEM
K043568 · HRX
Medtronic Sofamor Danek
Orthopedic · 29d
Cleared Jan 21, 2005
MALLORY-HEAD MODULAR CALCAR STEMS WITH INTERLOCKING SLOTS
K042774 · LPH
Biomet, Inc.
Orthopedic · 108d
Cleared Jan 21, 2005
MULTI-USE COMPRESSION SCREW
K043102 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 73d
Cleared Jan 21, 2005
TEMPFIX EXTERNAL FIXATION SYSTEM, MR SAFE
K043113 · KTT
DePuy Orthopaedics, Inc.
Orthopedic · 72d
Cleared Jan 21, 2005
PIONEER VERTEBRAL BODY REPLACEMENT DEVICE (PIONEER VERTEBRAL SPACER)
K043206 · MQP
Pioneer Surgical Technology
Orthopedic · 63d
Cleared Jan 21, 2005
ALLOGRAN-N-BONE VOID FILLER
K043514 · MQV
Biocomposites, Ltd.
Orthopedic · 32d
Cleared Jan 21, 2005
PERIARTICULAR LOCKING PLATES AND SCREWS, SERIES 2358 AND 2359
K043560 · HRS
Zimmer, Inc.
Orthopedic · 25d
Cleared Jan 19, 2005
PINN-ACL CROSSPIN
K043106 · HTY
Linvatec Corp.
Orthopedic · 71d
Cleared Jan 19, 2005
CHARLOTTE HIGH-DEMAND COMPRESSION SCREW
K043281 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 54d
Cleared Jan 18, 2005
SYNTHES (USA) EXTERNAL FIXATION COMPONENT LINE EXTENSION - MR SAFE
K043039 · KTT
Synthes (Usa)
Orthopedic · 75d
Cleared Jan 18, 2005
COMPRESSION STAPLE AND SIMPLE STAPLE
K043059 · JDR
Wrightmedicaltechnologyinc
Orthopedic · 74d
Cleared Jan 14, 2005
CONCORD Radiopaque Bone Cement
K042168 · NDN
Globus Medical, Inc.
Orthopedic · 158d
Cleared Jan 14, 2005
CABLING SYSTEM TROCHANTER HOOK
K043252 · JDQ
Smith & Nephew, Inc.
Orthopedic · 52d
Cleared Jan 14, 2005
TRIMED OSTEOTOMY PLATE
K043263 · HRS
TriMed, Inc.
Orthopedic · 51d
Cleared Jan 14, 2005
ISSYS PEDICLE SCREW SYSTEM
K043522 · KWP
Custom Spine, Inc.
Orthopedic · 25d
Cleared Jan 14, 2005
TAPERLOC 12/14 TAPER FEMORAL COMPONENTS
K043537 · LPH
Biomet, Inc.
Orthopedic · 23d
Cleared Jan 12, 2005
SMITH & NEPHEW HYBRID KNEE FEMORAL
K042896 · NPJ
Smith & Nephew, Inc.
Orthopedic · 84d
Cleared Jan 12, 2005
TRIATHLON POSTERIORLY STABILIZED (PS) FEMORAL COMPONENT
K042993 · JWH
Howmedica Osteonics Corp.
Orthopedic · 72d
Cleared Jan 12, 2005
SMITH & NEPHEW VIDEOARTHROSCOPE
K043395 · HRX
Smith & Nephew, Inc.
Orthopedic · 33d
Cleared Jan 12, 2005
MODIFICATION TO XIA SPINAL SYSTEM
K043473 · KWP
Stryker Spine
Orthopedic · 27d
Cleared Jan 10, 2005
DENALI SPINE SYSTEM
K042635 · KWP
K2m, LLC
Orthopedic · 105d
Cleared Jan 07, 2005
5.0 CANNULATED DRILL PIN, 6.0 CANNULATED DRILL-PIN
K033856 · KTT
Peter Stevens, MD
Orthopedic · 393d