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
10417–10440 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 04, 2006
COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE
K061779 · HSX
Smith & Nephew, Inc.
Orthopedic · 39d
Cleared Aug 04, 2006
RAYHACK LOW PROFILE LOCKING PLATE AND INSTRUMENTS
K061955 · HRS
Creative Medical Designs, Inc.
Orthopedic · 24d
Cleared Aug 03, 2006
LISFRANC PLATE
K060474 · HRS
New Deal, S.A.
Orthopedic · 161d
Cleared Aug 03, 2006
AVS ASL PEEK SPACER SYSTEM
K061836 · MQP
Stryker Spine
Orthopedic · 35d
Cleared Aug 03, 2006
TRIATHLON LOW PROFILE TIBIAL TRAY
K062037 · JWH
Howmedica Osteonics Corp.
Orthopedic · 15d
Cleared Aug 02, 2006
TRABECULAR METAL ACETABULAR REVISION SYSTEM CAGE
K061226 · LPH
Zimmer, Inc.
Orthopedic · 92d
Cleared Aug 02, 2006
EXCIA TOTAL HIP SYSTEM LATERAL OFFSET
K061344 · JDI
Aesculap, Inc.
Orthopedic · 79d
Cleared Aug 01, 2006
OXYGENLESS PACKAGING CONVERSION OF LEGACY CENTERPULSE STANDARD POLYETHYLENE...
K061882 · JWH
Zimmer, Inc.
Orthopedic · 29d
Cleared Jul 27, 2006
M2A MAGNUM 12/14 TAPER INSERTS AND ONE-PIECE MODULAR HEADS
K061423 · KWA
Biomet Manufacturing Corp
Orthopedic · 65d
Cleared Jul 27, 2006
SYNTHES (USA) 6.5 MM CANCELLOUS SCREWS
K061621 · HWC
Synthes (Usa)
Orthopedic · 45d
Cleared Jul 27, 2006
XIA TITANIUM SPINAL SYSTEM AND XIA STAINLESS STEEL SPINAL SYSTEM
K061854 · NKB
Stryker Spine
Orthopedic · 27d
Cleared Jul 26, 2006
BAR PEDICLE SCREW SPINAL FIXATION SYSTEM, MODEL 2020
K061162 · MNH
Applied Spine Technologies, Inc.
Orthopedic · 91d
Cleared Jul 26, 2006
ALTES BUTTRESS PLATING SYSTEM
K061482 · KWQ
Altiva Corp.
Orthopedic · 57d
Cleared Jul 26, 2006
PIN SCREW
K061599 · JDW
Bk Meditech, Co., Ltd.
Orthopedic · 48d
Cleared Jul 26, 2006
IFS CANNULATED BONE SCREW
K061620 · HWC
Internal Fixation Systems, Inc.
Orthopedic · 47d
Cleared Jul 25, 2006
EBI 5.5 HELICAL FLANGE SPINAL SYSTEM
K061441 · MNH
Ebi, L.P.
Orthopedic · 62d
Cleared Jul 25, 2006
HITCH LACTOSORB SUTURE ANCHOR
K061657 · JDR
Arthrotek, Inc.
Orthopedic · 42d
Cleared Jul 25, 2006
ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT
K061665 · HWC
Arthrex, Inc.
Orthopedic · 41d
Cleared Jul 25, 2006
CD HORIZON SPINAL SYSTEM
K061915 · MNH
Medtronic Sofamor Danek
Orthopedic · 19d
Cleared Jul 24, 2006
PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER)
K061151 · MQP
Pioneer Surgical Technology
Orthopedic · 90d
Cleared Jul 24, 2006
UNITY LX ANTEROLATERAL LUMBAR PLATE FIXATION SYSTEM
K061229 · KWQ
Blackstone Medical, Inc.
Orthopedic · 83d
Cleared Jul 24, 2006
VERSYS FIBER METAL MIDCOAT LOW HEAD CENTER HIP PROSTHESIS
K061786 · LPH
Zimmer, Inc.
Orthopedic · 28d
Cleared Jul 20, 2006
M-COR HIP REPLACEMENT SYSTEM
K053417 · LPH
Portland Orthopaedics Pty. , Ltd.
Orthopedic · 224d
Cleared Jul 20, 2006
REVERE STABILIZATION SYSTEM
K061202 · NKB
Globus Medical, Inc.
Orthopedic · 80d