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
9217–9240 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 06, 2009
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
K083642 · KWA
DePuy Orthopaedics, Inc.
Orthopedic · 87d
Cleared Mar 06, 2009
SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES
K083694 · HRS
Synthes (Usa)
Orthopedic · 84d
Cleared Mar 06, 2009
PARCUS V-LOX TITANIUM SUTURE ANCHOR,MODELS: 10251, 10252, 10257, 10258
K090075 · MBI
Parcus Medical, LLC
Orthopedic · 53d
Cleared Mar 06, 2009
EXPEDIUM SPINE SYSTEM
K090230 · NKB
Depuy Spine, Inc.
Orthopedic · 35d
Cleared Mar 04, 2009
MESA SPINAL SYSTEM
K080611 · MNH
K2m, Inc.
Orthopedic · 365d
Cleared Mar 04, 2009
AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM
K083311 · ODP
Aesculap Implant Systems, Inc.
Orthopedic · 114d
Cleared Mar 04, 2009
SYNTHES (USA) 3.5MM LOCKING ATTACHMENT PLATES
K083573 · HRS
Synthes (Usa)
Orthopedic · 91d
Cleared Mar 04, 2009
APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM
K083607 · HWC
Cayenne Medical, Inc.
Orthopedic · 89d
Cleared Mar 04, 2009
APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MM
K083612 · HWC
Cayenne Medical, Inc.
Orthopedic · 89d
Cleared Mar 04, 2009
MODIFICATION TO: LANX SPINAL FIXATION SYSTEM
K090252 · KWP
Lanx, Inc.
Orthopedic · 30d
Cleared Mar 03, 2009
R3 CONSTRAINED LINER, CONSTRAINED LINER
K083566 · KWZ
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Mar 02, 2009
REPROCESSED EXTERNAL FIXATION DEVICE
K083636 · KTT
Sterilmed, Inc.
Orthopedic · 83d
Cleared Feb 27, 2009
TIGER DISCECTOMY DEVICE
K081240 · HRX
Spinal Devices, LLC
Orthopedic · 302d
Cleared Feb 27, 2009
AVS TL PEEK SPACERS
K083661 · MAX
Stryker Corp.
Orthopedic · 79d
Cleared Feb 26, 2009
ZIMMER UNIVERSAL LOCKING SYSTEM 2.7 MM LOCKING PLATES AND SCREWS ( TIVANIUM...
K083654 · HRS
Zimmer, Inc.
Orthopedic · 78d
Cleared Feb 25, 2009
GRAFTYS HBS
K082498 · MQV
Graftys
Orthopedic · 180d
Cleared Feb 25, 2009
PACP
K083663 · KWQ
Pioneer Surgical Technology
Orthopedic · 77d
Cleared Feb 23, 2009
SOLAS ANATOMIX SPINAL SYSTEM
K083178 · MNI
Biotechni America Spine Group, Inc.
Orthopedic · 118d
Cleared Feb 20, 2009
TRANSITION STABILIZATION SYSTEM
K073439 · NQP
Globus Medical, Inc.
Orthopedic · 441d
Cleared Feb 20, 2009
FANNING-PAPPAS MODULAR KNEE BEARING
K081400 · JWH
Endotec, Inc.
Orthopedic · 277d
Cleared Feb 20, 2009
ADVANCE A-CLASS TIBIAL INSERT
K081479 · MBH
Wrightmedicaltechnologyinc
Orthopedic · 269d
Cleared Feb 20, 2009
INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE
K090177 · MQV
Inion OY
Orthopedic · 28d
Cleared Feb 20, 2009
GAMMA-BSM, BETA-BSM
K090242 · MQV
Etex Corp.
Orthopedic · 18d
Cleared Feb 19, 2009
ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, MODELS 6005-650-000, 6005-651-000
K083009 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 133d