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
6361–6384 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 22, 2014
REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP...
K133370 · LPH
Signature Orthopaedics Pty Limited
Orthopedic · 260d
Cleared Jul 22, 2014
VELOXTM INTERBODY FUSION SYSTEM
K140864 · ODP
U&I Corp.
Orthopedic · 110d
Cleared Jul 22, 2014
VIEW PLATING SYSTEM,REDUCE FRACTURE PLATING SYSTEM,BONE SCREW
K140876 · HRS
Icon Orthopedic Concepts, LLC Dba...
Orthopedic · 106d
Cleared Jul 22, 2014
VARIAX ELBOW PLATING SYSTEM
K141677 · HRS
Stryker Trauma AG
Orthopedic · 29d
Cleared Jul 21, 2014
BIOSURE HEALICOIL PK INTERFERENCE SCREW
K140879 · MBI
Smith & Nephew, Inc.
Orthopedic · 105d
Cleared Jul 21, 2014
EXCIA TOTAL HIP SYSTEM
K140915 · LZO
Aesculap Implant Systems, LLC
Orthopedic · 102d
Cleared Jul 18, 2014
MEDYSSEY ANTERIOR CERVICAL FUSION CAGE
K132732 · ODP
Medyssey USA, Inc.
Orthopedic · 318d
Cleared Jul 18, 2014
AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM
K140082 · PHX
Tornier S.A.S.
Orthopedic · 186d
Cleared Jul 18, 2014
JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND...
K141219 · HTN
Biomet Manufacturing Corp
Orthopedic · 67d
Cleared Jul 18, 2014
VARIAX DISTAL RADIUS PLATING SYSTEM
K141430 · HRS
Stryker Leibinger GmbH & Co KG
Orthopedic · 49d
Cleared Jul 18, 2014
ARTHREX PIP DART
K141577 · HTY
Arthrex, Inc.
Orthopedic · 35d
Cleared Jul 17, 2014
SHILLA GROWTH GUIDANCE SYSTEM
K140750 · PGM
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 114d
Cleared Jul 17, 2014
NUVIS ARTHROSCOPE
K140903 · HRX
Integrated Endoscopy, Inc.
Orthopedic · 99d
Cleared Jul 16, 2014
CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARPOON)
K140142 · MAX
Choicespine, LP
Orthopedic · 175d
Cleared Jul 16, 2014
BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC
K140844 · MQV
Synergy Biomedical, Inc.
Orthopedic · 105d
Cleared Jul 16, 2014
ACCULIF TL AND PL CAGE
K141217 · MAX
Stryker Corporation
Orthopedic · 65d
Cleared Jul 15, 2014
MILESTONE SPINAL SYSTEM
K133053 · MAX
Weigao Orthopaedic Device Co., Ltd.
Orthopedic · 291d
Cleared Jul 15, 2014
FLXFIT INTERVERTEBRAL BODY FUSION DEVICE
K133813 · MAX
Expanding Orthopedics, Inc.
Orthopedic · 211d
Cleared Jul 15, 2014
GMK SPHERE EXTENSION
K140826 · JWH
Medacta International
Orthopedic · 105d
Cleared Jul 14, 2014
PFX SPINOUS PROCESS FIXATION SYSTEM
K132765 · PEK
Innovasis, Inc.
Orthopedic · 313d
Cleared Jul 14, 2014
CONSENSUS VITALITE TIBIAL INSERT
K133919 · JWH
Consensus Orthopedics, Inc.
Orthopedic · 203d
Cleared Jul 14, 2014
CD HORIZON SPINAL SYSTEM
K141605 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared Jul 11, 2014
EXPRT REVISION KNEE
K140830 · JWH
Encore Medical, L.P.
Orthopedic · 100d
Cleared Jul 11, 2014
MAXLOCK EXTREME ELBOW FRACTURE SYSTEM
K141301 · HRS
Orthohelix Surgical Designs, Inc.
Orthopedic · 53d