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
9481–9504 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 24, 2008
MODIFICATION TO SINGLE PLANAR MULTI AXIS (SPMA) PEDICLE SCREW SYSTEM
K081790 · MNI
Trinity Orthopedics, LLC
Orthopedic · 29d
Cleared Jul 23, 2008
TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5
K073159 · HWC
Trauson (Jiangsu) Medical Instrument...
Orthopedic · 258d
Cleared Jul 23, 2008
COSMIC SYSTEM
K080841 · MNI
Ulrich GmbH & Co. KG
Orthopedic · 119d
Cleared Jul 23, 2008
LEGION HINGE KNEE SYSTEM
K081111 · KRO
Smith & Nephew, Inc.
Orthopedic · 96d
Cleared Jul 23, 2008
BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM
K081177 · MAX
Blackstone Medical, Inc.
Orthopedic · 89d
Cleared Jul 23, 2008
FIXXSURE CROSS LINK
K081331 · MNH
Spineworks, LLC
Orthopedic · 72d
Cleared Jul 23, 2008
SYNTHES (USA) TOMOFIX MEDIAL DISTAL FEMUR PLATES
K081353 · HRS
Synthes (Usa)
Orthopedic · 70d
Cleared Jul 22, 2008
TRITANIUM ACETABULAR SHELL SYSTEM
K081171 · LPH
Howmedica Osteonics Corp.
Orthopedic · 89d
Cleared Jul 22, 2008
PLEXUR M
K081227 · MQV
Osteotech, Inc.
Orthopedic · 83d
Cleared Jul 22, 2008
ORTHOPEDIATRICS PEDIPLATES SYSTEM
K081407 · HRS
OrthoPediatrics Corp.
Orthopedic · 64d
Cleared Jul 18, 2008
VARIAX DISTAL FIBULA PLATE
K081284 · KTT
Howmedica Osteonics Corp.
Orthopedic · 73d
Cleared Jul 18, 2008
SYNTHES (USA) STAINLESS STEEL ELASTIC INTRAMEDULLARY NAIL SYSTEM
K081452 · HSB
Synthes (Usa)
Orthopedic · 56d
Cleared Jul 18, 2008
MERETE 3.0 AND 3.5 MM LOCKING SCREWS
K081513 · HWC
Merete Medical GmbH
Orthopedic · 49d
Cleared Jul 18, 2008
SINTEA BIOTECH PLS MULTI-AXIAL SCREWS
K081631 · MNH
Sintea Biotech, Inc.
Orthopedic · 37d
Cleared Jul 17, 2008
AEQUALIS REVERSED SHOULDER PROSTHESIS
K081059 · PHX
Tornier
Orthopedic · 94d
Cleared Jul 17, 2008
COMPOSITE HITCH SUTURE ANCHOR
K081172 · JDR
Biomet Manufacturing Corp
Orthopedic · 84d
Cleared Jul 17, 2008
SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION
K081700 · HWC
Synthes (Usa)
Orthopedic · 30d
Cleared Jul 17, 2008
AEQUALIS SHOULDER FRACTURE AND SHOULDER SYSTEMS
K081707 · KWS
Tornier, Inc.
Orthopedic · 30d
Cleared Jul 16, 2008
ENDOBUTTON CONTINUOUS LOOP (CL)
K081098 · JDR
Smith & Nephew Inc., Endoscopy Division
Orthopedic · 90d
Cleared Jul 15, 2008
ORTHOMESH
K073115 · HRS
Synthes (Usa)
Orthopedic · 253d
Cleared Jul 14, 2008
CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR
K072291 · HWC
Conmed Linvatec
Orthopedic · 333d
Cleared Jul 14, 2008
MONOPOLY PEDICLE SCREW SYSTEM
K081108 · NKB
Signus Medical, LLC
Orthopedic · 87d
Cleared Jul 14, 2008
SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM
K081132 · KWQ
Spine Smith Partners L.P.
Orthopedic · 84d
Cleared Jul 14, 2008
SPINAL ELEMENTS BUTTRESS PLATE SYSTEM
K081418 · KWQ
Spinal Elements, Inc.
Orthopedic · 55d