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
6289–6312 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Sep 03, 2014
TRABECULAR METAL TIBIAL CONE BROACH, TRABECULAR METAL COUPLED TIBIAL CONE BROACH
K141840 · MBH
Zimmer, Inc.
Orthopedic · 57d
Cleared Sep 02, 2014
ORTHOFIX TL-HEX TRUE LOK HEXALOBE SYSTEM (TL-HEX)
K141078 · KTT
Orthofix Srl
Orthopedic · 130d
Cleared Sep 02, 2014
RENOVIS CEMENTED HIP SYSTEM
K141370 · JDI
Renovis Surgical Technologies, Inc.
Orthopedic · 98d
Cleared Aug 29, 2014
EVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS INSERTS
K140735 · MBH
Microport Orthopedics, Inc.
Orthopedic · 158d
Cleared Aug 29, 2014
DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM
K141796 · HRS
Synthes USA Products, LLC
Orthopedic · 57d
Cleared Aug 28, 2014
DISTAL ELBOW PLATING SYSTEM
K140892 · HRS
Skeletal Dynamics, LLC
Orthopedic · 142d
Cleared Aug 28, 2014
INFRONT LUMBAR INTERBODY FUSION SYSTEM
K141443 · MAX
Infront Medical, LLC
Orthopedic · 87d
Cleared Aug 28, 2014
ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7
K141821 · LZO
Exactech, Inc.
Orthopedic · 52d
Cleared Aug 28, 2014
REDUCE FRACTURE PLATING SYSTEM LINE EXTENSION
K142135 · HRS
Icon Orthopedic Concepts, LLC Dba...
Orthopedic · 24d
Cleared Aug 26, 2014
CONFIRM BIOACTIVE
K133678 · MQV
Globus Medical, Inc.
Orthopedic · 270d
Cleared Aug 26, 2014
VERTIFORM POSTERIOR FIXATION SYSTEM
K141291 · NKB
Next Orthosurgical
Orthopedic · 99d
Cleared Aug 25, 2014
ORTHOHUB EXTERNAL FIXATOR SOFTWARE
K140550 · OSN
Orthohub, Inc.
Orthopedic · 174d
Cleared Aug 22, 2014
IKNEE DISTAL FEMORAL CUTTING GUIDE
K140689 · OLO
Evergreen Orthopedic Research Lab
Orthopedic · 156d
Cleared Aug 22, 2014
NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE
K140946 · MQV
Novabone Products, LLC
Orthopedic · 130d
Cleared Aug 22, 2014
MERCURY SPINAL SYSTEM
K141372 · NKB
Spinal Elements, Inc.
Orthopedic · 87d
Cleared Aug 22, 2014
ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS
K141509 · PGM
Medos Sarl
Orthopedic · 77d
Cleared Aug 21, 2014
INTRAOSSEOUS FIXATION SYSTEM
K141004 · HTY
Orthohelix Surgical Designs, Inc.
Orthopedic · 125d
Cleared Aug 21, 2014
TENSYN BAND, TENSYN FRACTURE PLATES
K141264 · HTN
Dallen Medical, Inc.
Orthopedic · 98d
Cleared Aug 21, 2014
ROMEO 2 PAD POSTERIOR AXIAL DEVICE
K141508 · PEK
Spineart
Orthopedic · 76d
Cleared Aug 21, 2014
SMITH & NEPHEW DISPOSABLE FIN PUNCH
K141585 · JWH
Smith & Nephew, Inc.
Orthopedic · 69d
Cleared Aug 21, 2014
OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML
K141930 · NDN
Osseon, LLC
Orthopedic · 36d
Cleared Aug 21, 2014
VALOR HINDFOOT FUSION NAIL SYSTEM
K142121 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 17d
Cleared Aug 21, 2014
ORTHOHELIX STAPLE SYSTEM
K142148 · JDR
Orthohelix Surgical Designs, Inc.
Orthopedic · 16d
Cleared Aug 19, 2014
M.U.S.T PEDICLE SCREW SYSTEM
K141988 · NKB
Medacta International
Orthopedic · 28d