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
7753–7776 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 27, 2012
JOURNEY II DEEP DISHED ARTICULAR INSERTS
K113482 · JWH
Smith & Nephew, Inc.
Orthopedic · 96d
Cleared Feb 24, 2012
SINTEA PLUSTEK ANTERIOR CERVICAL PLATE SYSTEM
K112861 · KWQ
Sintea Plustek, LLC
Orthopedic · 147d
Cleared Feb 24, 2012
SMR MODULAR GLENOID-METAL-BACK SMR MODULAR GLENOID-LINER SMR MODULAR...
K113254 · PHX
Lima Corporate S.P.A.
Orthopedic · 113d
Cleared Feb 24, 2012
LINEAR HIP STEM, SIZE 5
K120241 · LPH
Encore Medical, L.P.
Orthopedic · 28d
Cleared Feb 23, 2012
KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT
K111970 · KRR
Tornier
Orthopedic · 227d
Cleared Feb 17, 2012
ACU-CUT VERTEBRAL AUGMENTATION SYSTEM
K113452 · NDN
Ascendx Spine, Inc.
Orthopedic · 88d
Cleared Feb 17, 2012
WAGNER CONE PROSTHESIS SYSTEM
K113556 · LZO
Zimmer GmbH
Orthopedic · 78d
Cleared Feb 17, 2012
ARTHREX KNOTLESS SUTURETAK ANCHOR
K120155 · MBI
Arthrex, Inc.
Orthopedic · 30d
Cleared Feb 17, 2012
ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM
K120163 · HRS
Acute Innovations, LLC
Orthopedic · 29d
Cleared Feb 16, 2012
EAUM TOTAL KNEE SYSTEM
K110404 · JWH
Corentec Co., Ltd.
Orthopedic · 367d
Cleared Feb 16, 2012
ICON (TM) MODULAR PEDICLE SCREW SYSTEM
K111448 · NKB
Orthofix, Inc.
Orthopedic · 268d
Cleared Feb 16, 2012
ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
K113518 · ODP
Spinefrontier, Inc.
Orthopedic · 79d
Cleared Feb 16, 2012
COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE
K120121 · PHX
Biomet, Inc.
Orthopedic · 30d
Cleared Feb 16, 2012
ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL
K120143 · ODP
Apollo Spine
Orthopedic · 29d
Cleared Feb 15, 2012
CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K113378 · JWH
Conformis, Inc.
Orthopedic · 91d
Cleared Feb 15, 2012
S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL...
K113409 · HSB
Howmedica Osteonics Corp.
Orthopedic · 89d
Cleared Feb 15, 2012
FOCUS SPINAL SYSTEM
K120140 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 28d
Cleared Feb 14, 2012
POLYFUSE - NEUROBONE
K111018 · MQV
Atpac Medical, LLC
Orthopedic · 308d
Cleared Feb 13, 2012
COFLEX-F
K112595 · KWP
Paradigm Spine, LLC
Orthopedic · 159d
Cleared Feb 10, 2012
SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)
K113362 · HRX
Spine View, Inc.
Orthopedic · 87d
Cleared Feb 09, 2012
CD HORIZON VOYAGER SPINAL SYSTEM
K113529 · NKB
Medtronic Sofamor Danek
Orthopedic · 71d
Cleared Feb 08, 2012
DEPUY PULSE THORACOLUMBAR SCREW SYSTEM
K113396 · NKB
Medos International SARL
Orthopedic · 93d
Cleared Feb 08, 2012
SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)
K120083 · HSB
Synthes (Usa)
Orthopedic · 28d
Cleared Feb 07, 2012
ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS
K111678 · HRS
Ortho Solutions Limited
Orthopedic · 237d