FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Orthopedic ×
17,985 results
4201–4224 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 05, 2018
SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices
K181531 · MAX
Spineex, Inc.
Orthopedic · 116d
Cleared Oct 04, 2018
Prase MIS Spinal System
K182059 · NKB
Gbs Commonwealth Co., Ltd.
Orthopedic · 65d
Cleared Oct 04, 2018
SYMPHONY™ OCT System
K181949 · NKG
Medos International SARL
Orthopedic · 76d
Cleared Oct 04, 2018
WishBone Medical Plate and Screw System
K180736 · HRS
Wishbone Medical, Inc.
Orthopedic · 196d
Cleared Oct 03, 2018
FIREFLY® Midline Navigation Guide
K181883 · PQC
Mighty Oak Medical, Inc.
Orthopedic · 82d
Cleared Oct 03, 2018
Outlet Sacroiliac Joint Fusion System
K181881 · OUR
Sij Surgical
Orthopedic · 82d
Cleared Oct 03, 2018
ARIX Clavicle System
K180972 · HRS
Jeil Medical Corporation
Orthopedic · 173d
Cleared Sep 28, 2018
Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay
K182039 · PHX
Arthrex, Inc.
Orthopedic · 60d
Cleared Sep 28, 2018
Truliant Porous Femoral Components
K181794 · MBH
Exactech, Inc.
Orthopedic · 85d
Cleared Sep 28, 2018
MICRORAPTOR Knotless Suture Anchor
K181746 · MAI
Smith and Nephew, Inc.
Orthopedic · 88d
Cleared Sep 28, 2018
Libertas Hip Replacement System
K180973 · JDI
Maxx Orthopedics, Inc.
Orthopedic · 168d
Cleared Sep 27, 2018
CoLink View Plating System
K182402 · HRS
In2bones USA, LLC
Orthopedic · 23d
Cleared Sep 27, 2018
CarboClear® Pedicle Screw System
K182377 · NKB
CarboFix Orthopedics , Ltd.
Orthopedic · 27d
Cleared Sep 27, 2018
Acculoc Total Knee System
K182370 · JWH
Rootloc Co., Ltd.
Orthopedic · 27d
Cleared Sep 27, 2018
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder...
K181742 · KWS
Stryker GmbH
Orthopedic · 87d
Cleared Sep 27, 2018
DualX
K181397 · MAX
Innovasive, Inc.
Orthopedic · 121d
Cleared Sep 26, 2018
Fixated Asfora BULLET CAGE® (FABC)
K181591 · MAX
Medical Designs, LLC
Orthopedic · 100d
Cleared Sep 25, 2018
OsseoScrew System
K181980 · NKB
Alphatec Spine, Inc.
Orthopedic · 62d
Cleared Sep 24, 2018
Comprehensive Reverse Shoulder System
K181611 · PHX
Biomet Manufacturing Corp
Orthopedic · 97d
Cleared Sep 24, 2018
REDAPT Porous Acetabular Shell
K181366 · LPH
Smith & Nephew, Inc.
Orthopedic · 124d
Cleared Sep 21, 2018
Spineology Navigation Instruments
K182345 · OLO
Spineology, Inc.
Orthopedic · 24d
Cleared Sep 21, 2018
Arthrex FiberTak Suture Anchor
K181769 · MBI
Arthrex, Inc.
Orthopedic · 80d
Cleared Sep 21, 2018
Tranquil-L Interbody System
K181702 · MAX
Nexus Spine, LLC
Orthopedic · 86d
Cleared Sep 21, 2018
DePuy Corail AMT Hip Prosthesis
K173960 · LZO
Depuy France S.A.S.
Orthopedic · 267d