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
6889–6912 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Sep 17, 2013
ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL AND STAINLESS STEEL TIBIAL NAIL
K130595 · HSB
Zimmer, Inc.
Orthopedic · 194d
Cleared Sep 17, 2013
5.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, 6.5MM MULTIFIX S KNOTLESS FIXATION...
K132590 · MBI
ArthroCare Corporation
Orthopedic · 29d
Cleared Sep 17, 2013
MAXLOCK EXTREME SYSTEM
K132591 · HRS
Orthohelix Surgical Designs, Inc.
Orthopedic · 29d
Cleared Sep 16, 2013
DEPUY CORAIL AMT HIP PROSTHESIS
K123991 · KWY
Depuy France S.A.S.
Orthopedic · 264d
Cleared Sep 16, 2013
NOVOKNEE TOTAL KNEE SYSTEM
K131398 · JWH
Novosource, Inc.
Orthopedic · 124d
Cleared Sep 16, 2013
RAMPART-O, RAMPART-T
K132053 · MAX
Spineology, Inc.
Orthopedic · 75d
Cleared Sep 13, 2013
LOGIC STAND-ALONE INTERVERTEBRAL BODY FUSION DEVICE
K130641 · OVD
Binder Biomedical, Inc.
Orthopedic · 186d
Cleared Sep 13, 2013
CAS PSI KNEE SYSTEM
K131409 · JWH
Orthosoft, Inc.
Orthopedic · 121d
Cleared Sep 12, 2013
VIVORTE BVF
K130703 · MBP
Vivorte, Inc.
Orthopedic · 181d
Cleared Sep 12, 2013
EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM
K131802 · OSH
Depuy Spine, A Johnson & Johnson Company
Orthopedic · 85d
Cleared Sep 12, 2013
ACCULIF TL AND PL CAGE
K132505 · MAX
Coalign Innovations, Inc.
Orthopedic · 31d
Cleared Sep 10, 2013
TIGER SPINE SYSTEM
K131250 · NKB
Corelink, LLC
Orthopedic · 131d
Cleared Sep 10, 2013
RETROGRADE FEMORAL NAIL
K132005 · HSB
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 71d
Cleared Sep 06, 2013
COMPREHENSIVE REVERSE SHOULDER SCREWS
K132239 · PHX
Biomet Manufacturing Corp
Orthopedic · 50d
Cleared Sep 06, 2013
SKYLINE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE ANTERIOR CERVICAL PLATE...
K132324 · KWQ
Medos International SARL
Orthopedic · 42d
Cleared Sep 05, 2013
ARIX FOOT SYSTEM
K131311 · HRS
Jeil Medical Corporation
Orthopedic · 121d
Cleared Sep 05, 2013
ACUMED WRIST SPANNING PLATE
K131764 · HRS
Acumed, LLC
Orthopedic · 80d
Cleared Sep 04, 2013
INTEGRA INTERSPINOUS PROCESS SYSTEM
K121924 · PEK
Seaspine, Inc.
Orthopedic · 429d
Cleared Sep 04, 2013
POLARIS SPINAL SYSTEM
K131615 · OSH
Biomet Spine (Aka Ebi, LLC)
Orthopedic · 93d
Cleared Sep 04, 2013
SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM
K131980 · NKB
Zimmer Spine, Inc.
Orthopedic · 68d
Cleared Sep 03, 2013
PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS...
K123907 · KRR
Biomet Manufacturing Corp
Orthopedic · 258d
Cleared Sep 03, 2013
ARDIS INTERBODY SYSTEM
K131242 · MAX
Zimmer Spine, Inc.
Orthopedic · 125d
Cleared Sep 03, 2013
VARILIFT-L INTERBODY FUSION DEVICE
K131296 · MAX
Wenzel Spine, Inc.
Orthopedic · 120d
Cleared Sep 03, 2013
INTERFUSE L INTERVERTEBRAL BODY FUSION DEVICE
K131540 · MAX
Vertebral Technologies, Inc.
Orthopedic · 97d