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
6865–6888 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 03, 2013
PICCOLO COMPOSITE NAILING SYSTEM
K132774 · HSB
CarboFix Orthopedics , Ltd.
Orthopedic · 28d
Cleared Oct 01, 2013
MPACT DM LINER CONVERTER
K131458 · LZO
Medacta International
Orthopedic · 134d
Cleared Sep 30, 2013
TYBER MEDICAL INTERBODY SYSTEM
K130573 · ODP
Tyber Medical, LLC
Orthopedic · 210d
Cleared Sep 30, 2013
ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS,...
K131845 · KWI
Acumed, LLC
Orthopedic · 101d
Cleared Sep 27, 2013
MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES
K131559 · KWS
Materialise NV
Orthopedic · 120d
Cleared Sep 27, 2013
ARTHREX UNIVERS APEX
K131633 · KWS
Arthrex, Inc.
Orthopedic · 115d
Cleared Sep 27, 2013
TRINITY ACETABULAR SYSTEM
K131647 · LZO
Corin USA
Orthopedic · 114d
Cleared Sep 26, 2013
PERIMETER INTERBODY FUSION DEVICE
K132700 · MAX
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Sep 25, 2013
ARTHREX COMPRESSION PLATES
K130510 · HRS
Arthrex, Inc.
Orthopedic · 210d
Cleared Sep 25, 2013
JAZZ SYSTEM
K132287 · OWI
Hogan Lovells US LLP
Orthopedic · 64d
Cleared Sep 23, 2013
ANATOMIC PEEK CERVICAL FUSION SYSTEM
K130177 · ODP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 241d
Cleared Sep 23, 2013
X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER
K130365 · OQG
Encore Medical, L.P.
Orthopedic · 222d
Cleared Sep 23, 2013
RELIANCE CERVICAL IBF SYSTEM
K131429 · ODP
Reliance Medical Systems, LLC
Orthopedic · 129d
Cleared Sep 23, 2013
T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE
K131888 · MQP
Medtronic Sofamor Danek, Inc.
Orthopedic · 90d
Cleared Sep 23, 2013
PIPELINE KNEE SYSTEM
K132046 · JWH
Pipeline Orthopedics
Orthopedic · 83d
Cleared Sep 20, 2013
COROENT SINGLE TAB SYSTEM
K131723 · OVD
Nuvasive, Inc.
Orthopedic · 100d
Cleared Sep 19, 2013
ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM
K130810 · HWC
Zimmer, Inc.
Orthopedic · 178d
Cleared Sep 19, 2013
RENOVIS BIPOLAR HIP SYSTEM
K131354 · KWY
Renovis Surgical Technologies, LLC
Orthopedic · 132d
Cleared Sep 19, 2013
OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00
K132479 · MAX
Interventional Spine, Inc.
Orthopedic · 42d
Cleared Sep 19, 2013
Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM...
K132513 · MBI
ArthroCare Corporation
Orthopedic · 38d
Cleared Sep 19, 2013
PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)
K132626 · LPH
Pipeline Biotechnology
Orthopedic · 28d
Cleared Sep 19, 2013
TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES
K132632 · MBI
Tornier, Inc.
Orthopedic · 28d
Cleared Sep 19, 2013
LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT...
K132644 · MNI
Corentec Co., Ltd.
Orthopedic · 24d
Cleared Sep 18, 2013
S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
K131122 · OVD
Renovis Surgical Technologies, LLC
Orthopedic · 149d