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
8833–8856 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 22, 2010
BIOFOAM BONE WEDGE MODEL ASSORTED
K093950 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 30d
Cleared Jan 21, 2010
TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK
K090953 · OLO
Praxim Medivision, SA
Orthopedic · 293d
Cleared Jan 21, 2010
QUANTUM M COMPOSITE NAILING SYSTEM
K091425 · HSB
N.M.B. Medical Applications, Ltd.
Orthopedic · 253d
Cleared Jan 21, 2010
AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II
K092124 · KWQ
Trans1 Incorporated
Orthopedic · 190d
Cleared Jan 21, 2010
MEDACTA TOTAL HIP PROTHESIS SYSTEM-AMISTEN H , QUADRA H, QUADRA S
K093944 · LZO
Medacta International S.A.
Orthopedic · 30d
Cleared Jan 20, 2010
WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX)
K092110 · HSB
Sonoma Orthopedic Products, Inc.
Orthopedic · 190d
Cleared Jan 19, 2010
BLADE ANTERIOR CERVICAL PLATE SYSTEM
K091936 · KWQ
Nexxt Medical, Inc.
Orthopedic · 203d
Cleared Jan 19, 2010
SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061
K092754 · HWC
Small Bone Innovations, Inc.
Orthopedic · 132d
Cleared Jan 19, 2010
LIFE SPINE LUMBAR PLATE SYSTEM
K093200 · KWQ
Life Spine
Orthopedic · 102d
Cleared Jan 14, 2010
ASCENSION METAL GREAT TOE SYSTEM
K092047 · KWD
Ascension Orthopedics, Inc.
Orthopedic · 192d
Cleared Jan 11, 2010
SYNTHES 7.3 MM CANNULATED SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREWS (SCFE)
K092909 · HWC
Synthes (Usa)
Orthopedic · 111d
Cleared Jan 11, 2010
OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES...
K093360 · JWH
Exactech, Inc.
Orthopedic · 75d
Cleared Jan 08, 2010
ORTHOSS
K090401 · MQV
Ed. Geistlich Soehne AG Fur Chemische...
Orthopedic · 325d
Cleared Jan 07, 2010
MOUNTAINEER LAMINOPLASTY SYSTEM
K091994 · NQW
Depuy Spine, Inc.
Orthopedic · 189d
Cleared Jan 07, 2010
EXACTECH EQUINOXE PLATFORM FRACTURE STEM AND REVISION PLATFORM FRACTURE STEM
K092900 · PHX
Exactech, Inc.
Orthopedic · 108d
Cleared Jan 07, 2010
MINI RAIL EXTERNAL FIXATOR SYSTEM
K093550 · KTT
Small Bone Innovations, Inc.
Orthopedic · 51d
Cleared Jan 06, 2010
4CIS PEEK, PLIF AND TLIF CAGE SYSTEM
K092162 · MAX
Solco Biomedical Co., Ltd.
Orthopedic · 174d
Cleared Dec 30, 2009
STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM...
K090986 · NDN
Dfine, Inc.
Orthopedic · 267d
Cleared Dec 29, 2009
SYNTHES MATRIX SYSTEM
K092929 · NKB
Synthes (Usa)
Orthopedic · 97d
Cleared Dec 23, 2009
CERVICORE CORPECTOMY CAGE
K091426 · MQP
Verticor, Ltd.
Orthopedic · 224d
Cleared Dec 23, 2009
SYNTHES (USA) 2.4MM LCP VOLAR COLUMN DISTAL RADIUS PLATES
K091644 · HRS
Synthes (Usa)
Orthopedic · 202d
Cleared Dec 23, 2009
CARDO MEDICAL ALIGN 360 MEDIALIZED PATELLA COMPONENT
K092803 · JWH
Cardo Medical Corp.
Orthopedic · 103d
Cleared Dec 23, 2009
CONMED LINVATEC INTERCEPT IMPLANT
K092998 · MBI
Linvatec Corp.
Orthopedic · 86d
Cleared Dec 23, 2009
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K093077 · MNI
Alphatec Spine, Inc.
Orthopedic · 84d