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
9529–9552 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 01, 2008
TLS FIXATION SYSTEM
K080974 · HWC
Fournitures Hospitalieres Industrie
Orthopedic · 88d
Cleared Jul 01, 2008
SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS
K081205 · JDQ
Synthes (Usa)
Orthopedic · 63d
Cleared Jun 30, 2008
L-VARLOCK
K080537 · MAX
Kiscomedica S.A.
Orthopedic · 124d
Cleared Jun 30, 2008
CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM LINE EXTENSION
K081564 · MQP
Creaspine
Orthopedic · 26d
Cleared Jun 30, 2008
MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM
K081620 · KWS
DePuy Orthopaedics, Inc.
Orthopedic · 21d
Cleared Jun 27, 2008
POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES
K080617 · HRX
Richard Wolf Medical Instruments Corp.
Orthopedic · 115d
Cleared Jun 27, 2008
MOUNTAINEER OCT SPINAL SYSTEM
K080828 · MNH
Depuy Spine, Inc.
Orthopedic · 94d
Cleared Jun 27, 2008
GPS, G SURGICAL PEDICLE SYSTEM
K081041 · MNH
G Surgical Co., Ltd.
Orthopedic · 77d
Cleared Jun 27, 2008
BIOMET PHOENIX ANKLE NAIL SYSTEM
K081243 · HSB
Biomet Trauma
Orthopedic · 57d
Cleared Jun 25, 2008
SOLITAIRE PEEK-OPTIMA ANTERIOR SPINAL SYSTEM
K081395 · OVD
Biomet Spine
Orthopedic · 37d
Cleared Jun 24, 2008
OSTAPEK VBR SYSTEM
K072326 · MQP
Co-Ligne AG
Orthopedic · 309d
Cleared Jun 24, 2008
MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS
K073556 · HRS
Medxpert GmbH
Orthopedic · 188d
Cleared Jun 24, 2008
ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION,...
K080879 · HTY
Bioretec, Ltd.
Orthopedic · 85d
Cleared Jun 20, 2008
CERAMENT BONE VOID FILLER, MODEL A0210
K073316 · MQV
Bonesupport AB
Orthopedic · 207d
Cleared Jun 20, 2008
MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II
K080368 · HSX
Mako Surgical Corp.
Orthopedic · 129d
Cleared Jun 20, 2008
MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR
K081428 · HWC
Biocomposites, Ltd.
Orthopedic · 30d
Cleared Jun 18, 2008
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM VOLAR DISTAL RADIUS LOCKING...
K081106 · HRS
Smith & Nephew, Inc.
Orthopedic · 61d
Cleared Jun 18, 2008
BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH...
K081392 · HWC
Bioretec, Ltd.
Orthopedic · 30d
Cleared Jun 17, 2008
E-POLY TIBIAL BEARINGS
K080528 · JWH
Biomet Orthopedics, Inc.
Orthopedic · 112d
Cleared Jun 17, 2008
ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD)
K080615 · MAX
Titan Spine, LLC
Orthopedic · 105d
Cleared Jun 17, 2008
ASCENSION PYROCARBON LUNATE
K080997 · KWN
Ascension Orthopedics, Inc.
Orthopedic · 70d
Cleared Jun 17, 2008
MODIFICATION TO CORAL SPINAL SYSTEM
K081414 · NKB
Theken Spine, LLC
Orthopedic · 28d
Cleared Jun 17, 2008
VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTE
K081439 · MQV
Orthovita, Inc.
Orthopedic · 26d
Cleared Jun 16, 2008
AXIS FIXATION SYSTEM
K062254 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 682d