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
7273–7296 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 04, 2013
K7C SPACER
K123388 · ODP
K7, LLC
Orthopedic · 63d
Cleared Jan 03, 2013
SUPER STAPLE(TM) CLASSIC
K123363 · JDR
Metric Medical Devices, Inc.
Orthopedic · 63d
Cleared Dec 28, 2012
ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL...
K121297 · LPH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 242d
Cleared Dec 28, 2012
DEPUY PULSE ANTERIOR CERVICAL IN-LINE PLATE SYSTEM
K123167 · KWQ
Medos International SARL
Orthopedic · 80d
Cleared Dec 27, 2012
A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE AIS)
K121693 · MAX
Sapphire Medical Group, Inc.
Orthopedic · 203d
Cleared Dec 27, 2012
FLEXLITE CAMERA
K122134 · HRX
Spine View, Inc.
Orthopedic · 162d
Cleared Dec 21, 2012
DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS
K112898 · LPH
Lima Corporate S.P.A.
Orthopedic · 445d
Cleared Dec 21, 2012
INTEGRA TOTAL FOOT SYSTEMS
K123000 · HRS
Integra LifeSciences Corporation
Orthopedic · 85d
Cleared Dec 21, 2012
ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON,...
K123341 · MBI
Arthrex, Inc.
Orthopedic · 51d
Cleared Dec 21, 2012
KYPHON EXPRESS II INFLATABLE BONE TAMPS
K123771 · HRX
Medtronic
Orthopedic · 14d
Cleared Dec 20, 2012
EXTERNAL FIXATOR SYSTEM
K122208 · NDK
Christopher D. Endara
Orthopedic · 148d
Cleared Dec 20, 2012
GKS PRIME FLEX CR TOTAL KNEE SYSTEM
K122975 · JWH
Permedica
Orthopedic · 85d
Cleared Dec 20, 2012
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K122991 · JWH
Conformis, Inc.
Orthopedic · 85d
Cleared Dec 20, 2012
STABILINK MIS SPINAL FIXATION SYSTEM
K123093 · KWP
Southern Spine, LLC
Orthopedic · 79d
Cleared Dec 19, 2012
CINCHER-2.6 SUTURE ANCHOR MODEL FG-001
K122954 · MBI
Foundry Newcoxi, Inc.
Orthopedic · 85d
Cleared Dec 18, 2012
VERTEX RECONSTRUCTION SYSTEM
K123568 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared Dec 17, 2012
COLUMBUS TOTAL KNEE SYSTEM AS COLUMBUS REVISION KNEE SYSTEM ENDURO KNEE SYSTEM
K120955 · JWH
Aesculap Implant Systems, LLC
Orthopedic · 262d
Cleared Dec 17, 2012
VERTIFLEX SPINOUS PROCESS FIXATION PLATE
K122509 · KWP
Vertiflex, Inc.
Orthopedic · 122d
Cleared Dec 14, 2012
ASCENDX VCF REDUCTION SYSTEM
K100404 · NDN
Aoi Medical, Inc.
Orthopedic · 1032d
Cleared Dec 14, 2012
ANODYNE ANTERIOR CERVICAL PLATE SYSTEM
K121514 · KWQ
Corelink, LLC
Orthopedic · 206d
Cleared Dec 14, 2012
MAXLOCK EXTREME SYSTEM MODEL MXL
K123203 · HRS
Orthohelix Surgical Designs, Inc.
Orthopedic · 63d
Cleared Dec 13, 2012
MILAGRO INTERFERENCE SCREWS
K122869 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 85d
Cleared Dec 12, 2012
MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM
K122571 · NKB
Seaspine, Inc.
Orthopedic · 111d
Cleared Dec 12, 2012
S4 SPINAL SYSTEM
K123352 · NKB
Aesculap Implant Systems, Inc.
Orthopedic · 42d