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
6121–6144 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 19, 2014
ARCAD COMPRESSIVE OSTEOSYNTHESIS STAPLE, EXPRESS COMPRESSIVE OSTEOSYNTHESIS...
K142111 · JDR
Novatsep
Orthopedic · 137d
Cleared Dec 19, 2014
POROSTEON PHUSION METAL CERVICAL CAGE
K142041 · ODP
Porosteon, Inc.
Orthopedic · 144d
Cleared Dec 18, 2014
Threshold Pedicular Fixation System
K143403 · NKB
Spineology, Inc.
Orthopedic · 20d
Cleared Dec 18, 2014
VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws
K143050 · HRS
Smith & Nephew, Inc.
Orthopedic · 56d
Cleared Dec 18, 2014
Echo Bi-Metric Microplasty Hip System
K143009 · LPH
Biomet, Inc.
Orthopedic · 59d
Cleared Dec 18, 2014
MAS PLIF Fixation system
K142737 · NKB
Nu Vasive, Incorporated
Orthopedic · 86d
Cleared Dec 18, 2014
SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura)...
K142488 · MAX
Seaspine, Inc.
Orthopedic · 105d
Cleared Dec 18, 2014
Bio2 CLM BG Bioactive Scaffold
K142463 · MQV
Bio2 Technologies, Inc.
Orthopedic · 107d
Cleared Dec 18, 2014
Interspinous Plate System
K142378 · PEK
Precision Spine, Inc.
Orthopedic · 114d
Cleared Dec 18, 2014
FASTFORWARD
K141420 · HTN
MedShape, Inc.
Orthopedic · 203d
Cleared Dec 18, 2014
ARTHREX SUTURETAK SUTURE ANCHORS
K140855 · MAI
Arthrex, Inc.
Orthopedic · 259d
Cleared Dec 16, 2014
Mini and Micro Fragments Reconstruction System-NEOFIX
K142419 · HRS
Neoortho Productos Orthopedicos S/A
Orthopedic · 110d
Cleared Dec 15, 2014
Stabilynx PEEK Suture Anchor
K142643 · MBI
D3 Dc, LLC /Stabilynx, Inc.
Orthopedic · 89d
Cleared Dec 15, 2014
ProxiFuse Hammer Toe Device
K142490 · HWC
Cartiva, Inc.
Orthopedic · 102d
Cleared Dec 15, 2014
NEXTGEN ALTIUS OCT SYSTEM
K140734 · KWP
Ebi, LLC
Orthopedic · 266d
Cleared Dec 11, 2014
iTotal Posterior Stabilized (PS) Knee Replacement System
K142404 · JWH
Conformis, Inc.
Orthopedic · 106d
Cleared Dec 11, 2014
IBIS PEDICLE SCREW SYSTEM
K142146 · NKB
Ortho Development Corp.
Orthopedic · 128d
Cleared Dec 11, 2014
G7 OSSEOTI ACETUBLAR SHELLS
K140669 · LPH
Biomet, Inc.
Orthopedic · 268d
Cleared Dec 10, 2014
Orthofix True Lok Hexapod System VI.3
K143125 · KTT
Orthofix Srl
Orthopedic · 40d
Cleared Dec 10, 2014
Crystal ®
K133218 · OVE
Spinal Elements, Inc.
Orthopedic · 418d
Cleared Dec 08, 2014
Valeo C Spacer System, Valeo II C IBF Device
K142264 · ODP
Amedica Corp.
Orthopedic · 115d
Cleared Dec 08, 2014
ORTHOFIX GALAXY WRIST
K141760 · KTT
Orthofix Srl
Orthopedic · 160d
Cleared Dec 08, 2014
HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS...
K141557 · HRX
Gallini Medical Devices, Srl
Orthopedic · 179d
Cleared Dec 05, 2014
TOTAL COMPRESSION PLATING SYSTEM
K143025 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 45d