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
3193–3216 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 04, 2020
KinematX Total Wrist Arthroplasty System
K191525 · JWJ
Extremity Medical, LLC
Orthopedic · 268d
Cleared Mar 03, 2020
Fixone Biocomposite Small Anchor
K192032 · MAI
Aju Pharm Co., Ltd.
Orthopedic · 217d
Cleared Mar 02, 2020
CarboClear Lumbar Cage System
K193378 · MAX
CarboFix Orthopedics , Ltd.
Orthopedic · 88d
Cleared Mar 02, 2020
Anjon Bremer Halo System
K193256 · JEC
Anjon Holdings, LLC
Orthopedic · 97d
Cleared Feb 28, 2020
Daytona® Small Stature Spinal System
K200381 · NKB
SeaSpine Orthopedics Corporation
Orthopedic · 10d
Cleared Feb 28, 2020
CONQUEST FN
K193029 · JDO
Smith & Nephew, Inc.
Orthopedic · 121d
Cleared Feb 28, 2020
Zimmer M/L Taper Hip Prosthesis
K192660 · LZO
Zimmer, Inc.
Orthopedic · 156d
Cleared Feb 28, 2020
Atlas Spine Expandable Cervical Standalone Interbody System
K192570 · OVE
Atlas Spine, Inc.
Orthopedic · 163d
Cleared Feb 28, 2020
Superelastic Staple
K192447 · JDR
Neosteo
Orthopedic · 175d
Cleared Feb 27, 2020
Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads
K192683 · LZO
Biomet UK, Ltd.
Orthopedic · 154d
Cleared Feb 27, 2020
Pitkar Locked Plating System
K192619 · HRS
S.H.Pitkar Orthotools Pvt. , Ltd.
Orthopedic · 157d
Cleared Feb 27, 2020
Omnia Medical Trauma Screws
K192096 · HWC
Omnia Medical, LLC
Orthopedic · 206d
Cleared Feb 26, 2020
NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical...
K193506 · MQP
Nu Vasive, Incorporated
Orthopedic · 70d
Cleared Feb 26, 2020
DePuy Synthes Hammertoe Continuous Compression Implant
K191463 · JDR
Synthes USA Products, LLC
Orthopedic · 268d
Cleared Feb 25, 2020
Trigon HA Stand-Alone Wedge Fixation System
K193414 · PLF
Nvision Biomedical Technologies, Inc.
Orthopedic · 78d
Cleared Feb 24, 2020
Titanium Interference Screws
K193451 · HWC
Biomet, Inc.
Orthopedic · 73d
Cleared Feb 24, 2020
NEXXT MATRIXX System
K193412 · PLR
Nexxt Spine, LLC
Orthopedic · 77d
Cleared Feb 24, 2020
Alliance Augmented Glenoid
K193180 · KWS
Zimmer, Inc.
Orthopedic · 98d
Cleared Feb 24, 2020
DELTA XTEND(TM) Reverse Shoulder System
K192855 · PHX
Depuy(Ireland)
Orthopedic · 143d
Cleared Feb 23, 2020
T2 Alpha Tibia Nailing System, IMN Screws System
K193308 · HSB
Stryker Trauma GmbH
Orthopedic · 86d
Cleared Feb 21, 2020
Glenoid Baseplate with Screw
K192799 · PHX
Fx Shoulder USA, Inc.
Orthopedic · 144d
Cleared Feb 21, 2020
Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia...
K190363 · MAX
Omnia Medical, LLC
Orthopedic · 371d
Cleared Feb 20, 2020
WIN Flexible Nail System
K193533 · JDS
Biomet, Inc.
Orthopedic · 62d
Cleared Feb 20, 2020
Largo PEEK Interbody System
K193255 · MAX
Flospine, LLC
Orthopedic · 86d