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
3313–3336 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 13, 2019
Corelink Navigation Instruments
K182731 · OLO
Corelink, LLC
Orthopedic · 441d
Cleared Dec 12, 2019
Arthrex 3.9mm Corkscrew Suture Anchor
K193157 · MAI
Arthrex, Inc.
Orthopedic · 28d
Cleared Dec 12, 2019
Invictus™ Spinal Fixation System
K192938 · NKB
Alphatec Spine, Inc.
Orthopedic · 55d
Cleared Dec 12, 2019
Genesys Spine 3DP Lumbar Interbody System
K182987 · MAX
Genesys Spine
Orthopedic · 409d
Cleared Dec 11, 2019
TSolution One Total Knee Application
K193135 · OLO
THINK Surgical, Inc.
Orthopedic · 29d
Cleared Dec 11, 2019
LOSPA II Knee System
K192507 · JWH
Corentec Co., Ltd.
Orthopedic · 90d
Cleared Dec 09, 2019
Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System,...
K191793 · HRS
Nebula Surgical Private Limited
Orthopedic · 159d
Cleared Dec 06, 2019
Avenir Muller Stem, Avenir Cemented Hip Stem
K193030 · LZO
Zimmer GmbH
Orthopedic · 37d
Cleared Dec 06, 2019
Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings
K190656 · LPH
Zimmer, Inc.
Orthopedic · 267d
Cleared Dec 05, 2019
BC Reflex Uni Knee System
K191996 · HSX
Bodycad Laboratories, Inc.
Orthopedic · 132d
Cleared Dec 05, 2019
G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular...
K190660 · LPH
Zimmer, Inc.
Orthopedic · 266d
Cleared Dec 04, 2019
TRACKER Kyphoplasty System
K192335 · NDN
GS Medical Co., Ltd.
Orthopedic · 98d
Cleared Dec 03, 2019
M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System
K193083 · OUR
Medacta International S.A.
Orthopedic · 28d
Cleared Dec 03, 2019
Exsomed Wrist Plating System
K192473 · HRS
Exsomed Corporation
Orthopedic · 84d
Cleared Dec 03, 2019
SeaSpine Beachside System
K192132 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 118d
Cleared Dec 02, 2019
Hi-Fatigue Bone Cement
K192394 · LOD
Osartis GmbH
Orthopedic · 90d
Cleared Dec 02, 2019
Vital Navigation System
K191722 · OLO
Zimmer Biomet Spine, Inc.
Orthopedic · 158d
Cleared Dec 02, 2019
Integra TITAN Reverse Shoulder System
K190588 · PHX
Integra LifeSciences Corporation
Orthopedic · 270d
Cleared Nov 30, 2019
Resorbable Mesh Device
K193040 · MQV
SeaSpine Orthopedics Corporation
Orthopedic · 30d
Cleared Nov 29, 2019
Shoulder Innovations Total Shoulder System
K192365 · KWT
Shoulder Innovations, Inc.
Orthopedic · 91d
Cleared Nov 27, 2019
Hi-Fatigue G Bone Cement
K192379 · LOD
Osartis GmbH
Orthopedic · 89d
Cleared Nov 27, 2019
World Knee Total Knee Systems
K190577 · JWH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 266d
Cleared Nov 26, 2019
DePuy Corail AMT Hip Prosthesis
K192946 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 39d
Cleared Nov 26, 2019
Pinnacle Duofix HA Acetabular Cup Prosthesis
K192919 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 42d