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
8953–8976 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 01, 2009
DYNESYS TOP-LOADING SPINAL SYSTEM
K092234 · NQP
Zimmer Spine, Inc.
Orthopedic · 70d
Cleared Sep 30, 2009
PARCUS PPEK CF INTERFERENCE SCREW
K091093 · HWC
Parcus Medical, LLC
Orthopedic · 167d
Cleared Sep 30, 2009
PARCUS V-LOX PEEK CF SUTURE ANCHOR, MODELS: 10253, 10254, 10263, 10264
K091094 · MBI
Parcus Medical, LLC
Orthopedic · 167d
Cleared Sep 29, 2009
PERIMETER INTERBODY FUSION DEVICE
K090353 · MAX
Medtronic Sofamor Danek
Orthopedic · 230d
Cleared Sep 29, 2009
JOURNEY BCS KNEE SYSTEM
K091014 · JWH
Smith & Nephew, Inc.
Orthopedic · 173d
Cleared Sep 28, 2009
KAINOS+
K090387 · MQV
Signus Medizintechnik GmbH
Orthopedic · 223d
Cleared Sep 28, 2009
DBX DEMINERALIZED BONE MATRIX PUTTY
K091218 · MQV
Musculoskeletal Transplant Foundation
Orthopedic · 154d
Cleared Sep 28, 2009
ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-HIP
K091998 · OLO
Mako Surgical Corp.
Orthopedic · 88d
Cleared Sep 25, 2009
BIOMET MODULAR FEMORAL REVISION SYSTEM
K090757 · KWA
Biomet, Inc.
Orthopedic · 186d
Cleared Sep 25, 2009
FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL COMPONENT
K091280 · JWH
Maxx Orthopedics, Inc.
Orthopedic · 147d
Cleared Sep 25, 2009
KNEEALIGN SYSTEM
K091411 · OLO
Orthalign, Inc.
Orthopedic · 135d
Cleared Sep 25, 2009
VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX,...
K091946 · MQP
Stryker Spine
Orthopedic · 87d
Cleared Sep 25, 2009
SPINAL USA INTERBODY CAGES
K092193 · MAX
Spinal USA
Orthopedic · 66d
Cleared Sep 25, 2009
SYNTHES LOCKING HAND PLATES
K092247 · HRS
Synthes (Usa)
Orthopedic · 59d
Cleared Sep 25, 2009
FIREBIRD SPINAL FIXATION SYSTEM
K092624 · NKB
Blackstone Medical, Inc.
Orthopedic · 30d
Cleared Sep 25, 2009
MODIFICATION TO: EXPEDIUM SPINE SYSTEM
K092626 · NKB
Depuy Spine, Inc.
Orthopedic · 29d
Cleared Sep 25, 2009
MANTIS REDUX SPINAL SYSTEM
K092631 · NKB
Stryker Spine
Orthopedic · 30d
Cleared Sep 25, 2009
SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SCREW
K092646 · HSB
Synthes (Usa)
Orthopedic · 28d
Cleared Sep 24, 2009
MODIFICATION TO BEACON STABILIZATION SYSTEM
K092610 · NKB
Globus Medical, Inc.
Orthopedic · 30d
Cleared Sep 23, 2009
APTUS K-WIRE SYSTEM
K092038 · HTY
Medartis AG
Orthopedic · 79d
Cleared Sep 23, 2009
VARIAX ELBOW SYSTEM LINE EXTENSION
K092671 · HRS
Howmedica Osteonics Corp.
Orthopedic · 23d
Cleared Sep 22, 2009
EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEM
K092143 · MEH
Aesculap Implant Systems, Inc.
Orthopedic · 69d
Cleared Sep 21, 2009
TORNIER, PITON FIXATION IMPLANT SYSTEM
K091870 · MBI
Tornier
Orthopedic · 90d
Cleared Sep 21, 2009
T2 SPINAL SYSTEM
K091883 · MQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 89d