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
11713–11736 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 15, 2003
BIO-INTRAFIX TIBIAL SCREW AND SHEATH
K032167 · HWC
Mitek Worldwide
Orthopedic · 91d
Cleared Oct 15, 2003
GENESIS II POROUS PLUS HA KNEE SYSTEM
K032683 · MBH
Smith & Nephew, Inc.
Orthopedic · 47d
Cleared Oct 10, 2003
ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL01
K031471 · KWP
Ortho Tec, LLC
Orthopedic · 154d
Cleared Oct 10, 2003
PROVEN REVISION FEMORAL AND PROVEN REVISION TIBIAL INSERT
K031901 · JWH
Stelkast Company
Orthopedic · 112d
Cleared Oct 10, 2003
KLS-MARTIN STERNAL PLATING SYSTEM
K032413 · HRS
KLS-Martin L.P.
Orthopedic · 66d
Cleared Oct 09, 2003
NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS
K031061 · MBH
Zimmer, Inc.
Orthopedic · 189d
Cleared Oct 09, 2003
SHIRAZ-JAVA SPINAL FIXATION SYSTEM
K031265 · MNH
Spine Next SA
Orthopedic · 171d
Cleared Oct 09, 2003
ACCOLADE-J HIP STEM SERIES
K032300 · MEH
Howmedica Osteonics Corp.
Orthopedic · 76d
Cleared Oct 09, 2003
SONOMA ANTERIOR CERVICAL PLATE SYSTEM
K032368 · KWQ
Seaspine
Orthopedic · 69d
Cleared Oct 09, 2003
FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM
K032427 · JEC
Meridan Medical
Orthopedic · 64d
Cleared Oct 09, 2003
GLOBAL MODULAR REPLACEMENT SYSTEM ANTEVERTED PROMIMAL FEMORAL COMPONENT
K032581 · LPH
Howmedica Osteonics Corp.
Orthopedic · 49d
Cleared Oct 09, 2003
BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS
K032700 · MQP
Blackstone Medical, Inc.
Orthopedic · 37d
Cleared Oct 09, 2003
T2 RECON NAIL SYSTEM
K032898 · HSB
Howmedica Osteonics Corp.
Orthopedic · 22d
Cleared Oct 08, 2003
ENDOTINE FOREHEAD DEVICE
K032770 · HWC
Coapt Systems, Inc.
Orthopedic · 30d
Cleared Oct 07, 2003
ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE,...
K032098 · HWC
Arthrex, Inc.
Orthopedic · 91d
Cleared Oct 07, 2003
NUVASIVE CEMENT RESTRICTOR
K032180 · JDK
Nuvasive, Inc.
Orthopedic · 82d
Cleared Oct 06, 2003
NORMED COMPRESSION BONE SCREW SYSTEM
K032634 · JDS
Noviace Corporation
Orthopedic · 41d
Cleared Oct 06, 2003
ACE NANCY NAIL
K032687 · HTY
DePuy Orthopaedics, Inc.
Orthopedic · 38d
Cleared Oct 03, 2003
EPSILON DURASUL CONSTRAINED ACETABULAR LINER
K030923 · KWZ
Centerpulse Orthopedics, Inc.
Orthopedic · 193d
Cleared Oct 02, 2003
HLS NOETOS SYSTEM
K032079 · JWH
Tornier
Orthopedic · 87d
Cleared Oct 01, 2003
LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE
K032072 · HWC
Arthrotek, Inc.
Orthopedic · 90d
Cleared Oct 01, 2003
DISTAL RADIUS FRACTURE REPAIR SYSTEM
K032705 · LXT
Hand Innovations, Inc.
Orthopedic · 29d
Cleared Oct 01, 2003
TRIGEN STRAIGHT HUMERAL NAIL SYSTEM
K032722 · HSB
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Sep 29, 2003
DEPUY 1 GENTAMICIN BONE CEMENT
K023103 · LOD
DePuy Orthopaedics, Inc.
Orthopedic · 376d