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
9601–9624 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 12, 2008
CAPSURE PS (R) SPINE SYSTEM
K081228 · MNI
Spine Wave, Inc.
Orthopedic · 12d
Cleared May 09, 2008
SHELL CAGE, WAVE CAGE, LOOP CAGE
K080401 · MAX
Advanced Medical Technologies AG
Orthopedic · 85d
Cleared May 09, 2008
METHA SHORT STEM HIP SYSTEM
K080584 · MEH
Aesculap Implant System, Inc.
Orthopedic · 67d
Cleared May 08, 2008
MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM
K072251 · LZJ
Merete Medical GmbH
Orthopedic · 269d
Cleared May 08, 2008
MODIFICATION TO EXPEDIUM SPINE SYSTEM
K080313 · NKB
Depuy Spine, Inc.
Orthopedic · 92d
Cleared May 08, 2008
SMITH & NEPHEW MIS HIP STEM WITH STIKTITE
K080625 · LPH
Smith & Nephew, Inc.
Orthopedic · 64d
Cleared May 07, 2008
LDR SPINE ROI-T IMPLANT
K080569 · MQP
Ldr Spine USA
Orthopedic · 68d
Cleared May 06, 2008
NOVABONE PUTTY- BIOACTIVE SYNTHETIC GRAFT
K080009 · MQV
Novabone Products, LLC
Orthopedic · 124d
Cleared May 06, 2008
AOS PROXIMAL HUMERAL PLATE
K080590 · KTW
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 64d
Cleared May 06, 2008
EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS
K080980 · MEH
Exactech, Inc.
Orthopedic · 29d
Cleared May 06, 2008
ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM
K081007 · KWA
Zimmer, Inc.
Orthopedic · 28d
Cleared May 02, 2008
CAIS STAPLE
K073281 · JDR
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 163d
Cleared May 02, 2008
OSFERION
K080065 · MQV
Olympus Terumo Biomaterials Corporation
Orthopedic · 113d
Cleared May 02, 2008
C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM
K080646 · KWQ
Biomet Spine
Orthopedic · 57d
Cleared May 02, 2008
DSS STABILIZATION SYSTEM
K080963 · NQP
Paradigm Spine
Orthopedic · 28d
Cleared May 01, 2008
AESCULAP PEEK INTERVERTEBRAL BODY FUSION SYSTEM: A SPACE, CESPACE, PROSPACE,...
K071983 · MAX
Aesculap Implant Systems, Inc.
Orthopedic · 287d
Cleared May 01, 2008
PATHWAY
K080281 · MAX
Custom Spine, Inc.
Orthopedic · 87d
Cleared May 01, 2008
X-MESH EXPANDABLE CAGE SYSTEM
K080568 · MQP
Depuy Spine, Inc.
Orthopedic · 62d
Cleared May 01, 2008
SYNTHES 6.5MM MIDFOOT FUSION BOLT
K081071 · HWC
Synthes (Usa)
Orthopedic · 16d
Cleared Apr 30, 2008
MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM
K080429 · KWQ
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 71d
Cleared Apr 30, 2008
XIA SPINAL SYSTEM, STAINLESS STEEL UNI-PLANAR SCREWS
K080928 · NKB
Stryker Spine
Orthopedic · 28d
Cleared Apr 29, 2008
MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM
K080790 · KWP
Theken Spine, LLC
Orthopedic · 40d
Cleared Apr 28, 2008
TRANS1 AXIALIF 2-LEVEL OR II SYSTEM
K073643 · KWQ
Trans1 Incorporated
Orthopedic · 124d
Cleared Apr 28, 2008
CAP PLUS, EQUIVABONE, CAP/DBM
K080329 · MBP
Etex Corp.
Orthopedic · 81d