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
6097–6120 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Apr 30, 2015
INCITE ANCHORED CERVICAL INTERBODY DEVICE
K150913 · OVE
Incite Innovation
Orthopedic · 24d
Cleared Apr 30, 2015
G3 Active Plate Large Fragment System
K150649 · HRS
Genesis Fracture Care, Inc.
Orthopedic · 49d
Cleared Apr 29, 2015
aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping,...
K150974 · HWC
Aap Implantate AG
Orthopedic · 16d
Cleared Apr 29, 2015
Cardinal Health External Fixation System
K150579 · KTT
Cardinalhealth
Orthopedic · 51d
Cleared Apr 29, 2015
DARCO Locking Bone Plate System
K150520 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 58d
Cleared Apr 29, 2015
Arthrex Plates, Screws, and Staples
K150456 · HRS
Arthrex, Inc.
Orthopedic · 68d
Cleared Apr 29, 2015
Republic Spine Dark Star Spinal System
K150283 · MNH
Republic Spine, LLC
Orthopedic · 83d
Cleared Apr 29, 2015
PHALINX Hammertoe System
K150252 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 85d
Cleared Apr 29, 2015
SMV Scientific 4.5 mm Bone Screws
K150188 · HWC
Summit Medventures
Orthopedic · 92d
Cleared Apr 29, 2015
NuVasive(R) CCX-L Interbody System
K143595 · MAX
Nu Vasive, Incorporated
Orthopedic · 132d
Cleared Apr 29, 2015
Reliance Posterior Cervical-Thoracic System
K142867 · KWP
Reliance Medical Systems, LLC
Orthopedic · 210d
Cleared Apr 29, 2015
Zavation Posterior LEIF
K142392 · MAX
Zavation, LLC
Orthopedic · 245d
Cleared Apr 28, 2015
KYPHON (R) HV-R(R) Bone Cement
K150460 · NDN
Medtronic Sofamor Danck USA, Inc.
Orthopedic · 64d
Cleared Apr 28, 2015
Streamline OCT Occipito-Cervico-Thoracic System
K150254 · KWP
Pioneer Surgical Technology, Inc....
Orthopedic · 84d
Cleared Apr 28, 2015
Facet-Link Stabilization Platform
K150223 · MRW
Facet-Link, Inc.
Orthopedic · 88d
Cleared Apr 24, 2015
SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System
K150017 · OUR
Spinefrontier, Inc.
Orthopedic · 109d
Cleared Apr 23, 2015
PRECICE Intramedullary Limb Lengthening System
K150656 · HSB
Ellipse Technologies, Incorporated
Orthopedic · 41d
Cleared Apr 23, 2015
Aequalis PerFORM+ Shoulder System
K150583 · KWS
Tornier, Inc.
Orthopedic · 45d
Cleared Apr 23, 2015
Zimmer Nexel Total Elbow Ulnar Cement Diverter
K150501 · JDC
Zimmer, Inc.
Orthopedic · 56d
Cleared Apr 23, 2015
NuVasive Reline System
K143684 · NKB
Nu Vasive, Incorporated
Orthopedic · 120d
Cleared Apr 23, 2015
SOLSTICE OCT System
K142253 · KWP
Life Spine, Inc.
Orthopedic · 252d
Cleared Apr 23, 2015
INTERBODY CAGE
K140348 · MAX
Eisertech, LLC
Orthopedic · 436d
Cleared Apr 22, 2015
VENUS Spinal Fixation System
K143363 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 149d
Cleared Apr 20, 2015
PROFEMUR Preserve Size 1-3 Hip Stems
K150133 · LZO
Microport Orthopedics, Inc.
Orthopedic · 89d