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
9097–9120 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 15, 2009
CLAVICLE PLATING SYSTEM
K090289 · HRS
Orthohelix Surgical Designs, Inc.
Orthopedic · 130d
Cleared Jun 12, 2009
E-MATRIX GRAFT BONE EXTENDER
K083449 · MQV
Pioneer Surgical Technology
Orthopedic · 203d
Cleared Jun 12, 2009
TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM...
K090961 · LXC
Twin Star Medical, Inc.
Orthopedic · 67d
Cleared Jun 12, 2009
DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS
K090998 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 65d
Cleared Jun 11, 2009
PERPOS FCD-2 SYSTEM (SINGLE PATIENT USE), ANCHOR, STABILIZER
K090767 · MRW
Interventional Spine, Inc.
Orthopedic · 80d
Cleared Jun 10, 2009
VIPER 2 SYSTEM
K090648 · NKB
Depuy Spine, Inc.
Orthopedic · 91d
Cleared Jun 10, 2009
THEKEN CORAL SPINAL SYSTEM
K091266 · NKB
Theken Spine, LLC
Orthopedic · 41d
Cleared Jun 09, 2009
MAXMORESPINE SPINAL SYSTEM
K090132 · HRX
Hoogland Spine Products, GmbH
Orthopedic · 139d
Cleared Jun 08, 2009
SMITH & NEPHEW RAIL SYSTEM
K090926 · KTT
Smith & Nephew, Inc.
Orthopedic · 67d
Cleared Jun 05, 2009
CORTOSS BONE AUGMENTATION MATERIAL
K080108 · NDN
Orthovita, Inc.
Orthopedic · 507d
Cleared Jun 04, 2009
COLUMBUS REVISION KNEE SYSTEM
K083772 · JWH
Aesculap Implant System, Inc.
Orthopedic · 168d
Cleared Jun 04, 2009
SMITH & NEPHEW, INC. VLP FOOT PLATING, SCREW SYSTEM AND ACCESSORIES
K090675 · HRS
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared Jun 04, 2009
THORACOLUMBAR PLATE, MODEL 1208-41FXX, LUMBER PLATE, MODEL 1208-41FXXL,...
K091253 · KWQ
K2m, Inc.
Orthopedic · 36d
Cleared Jun 03, 2009
OPUS SPEEDLOCK KNOTLESS FIXATION DEVICE
K090615 · MBI
Arthrocare Corp.
Orthopedic · 86d
Cleared Jun 03, 2009
INTERTAN CHS LIMITED COLLAPSE SET SCREW
K090656 · HWC
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared Jun 02, 2009
MASTERGRAFT STRIP
K082166 · MQV
Medtronic Sofamor Danek
Orthopedic · 306d
Cleared Jun 02, 2009
NEXLINK OCT SYSTEM, MODEL 7000 SERIES
K090060 · KWP
Abbott Spine, Inc.
Orthopedic · 144d
Cleared Jun 01, 2009
EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM
K090415 · KWQ
Eminent Spine
Orthopedic · 103d
Cleared Jun 01, 2009
PATHWAY AVID
K090566 · MAX
Custom Spine, Inc.
Orthopedic · 90d
Cleared Jun 01, 2009
MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT
K091069 · HWC
Medacta International S.A.
Orthopedic · 48d
Cleared May 27, 2009
REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1
K082419 · MQV
Intra-Lock International, Inc.
Orthopedic · 278d
Cleared May 27, 2009
SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE
K083118 · ODP
Spinal USA
Orthopedic · 217d
Cleared May 27, 2009
SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM V 1.0
K090420 · OLO
Smith & Nephew, Inc.
Orthopedic · 98d
Cleared May 26, 2009
FUSION MEDICAL CANNULATED SCREW SYSTEM
K081122 · HWC
John Riccio
Orthopedic · 400d