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
8329–8352 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 10, 2011
VENUS ANTERIOR CERVICAL PLATE
K103137 · KWQ
Verticor, Ltd.
Orthopedic · 108d
Cleared Feb 09, 2011
FUSE PLIF CAFE
K100945 · MAX
Advanced Medical Technologies AG
Orthopedic · 309d
Cleared Feb 09, 2011
VENUS BASIC SPINAL FIXATION SYSTEM
K103085 · MNH
L & K Biomed Co., Ltd.
Orthopedic · 113d
Cleared Feb 09, 2011
HAMMERLOC TM TIBIAL FIXATION DEVICE
K103145 · MBI
Biomet Sports Medicine
Orthopedic · 107d
Cleared Feb 08, 2011
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
K103040 · NKB
Lanx, LLC
Orthopedic · 118d
Cleared Feb 08, 2011
LEUCADIA PEDICLE SCREW SYSTEM
K103102 · MNI
Phygen, LLC
Orthopedic · 111d
Cleared Feb 08, 2011
TRILLIANT SURGICAL SUBTALAR IMPLANT
K103183 · HWC
Trilliant Surgical, Ltd.
Orthopedic · 103d
Cleared Feb 08, 2011
SMITH & NEPHEW, INC SPATIALFRAME V4.1 WEB-BASED SOFTWARE
K110069 · KTT
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Feb 07, 2011
COROENT INTERLOCK SYSTEM
K102547 · OVE
Nuvasive, Inc.
Orthopedic · 157d
Cleared Feb 07, 2011
VITOSS BA BIMODAL BIOACTIVE BONE GRAFT SUBSTITUTE
K103173 · MQV
Orthovita, Inc.
Orthopedic · 102d
Cleared Feb 07, 2011
5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL
K110164 · MBI
Arthrocare Corp.
Orthopedic · 19d
Cleared Feb 04, 2011
GOLDEN GATE ANTERIOR PLATE SYSTEM
K101353 · KWQ
Ulrich GmbH & Co. KG
Orthopedic · 266d
Cleared Feb 04, 2011
COHESION BONE CEMENT
K103816 · NDN
Teknimed Sas
Orthopedic · 37d
Cleared Feb 03, 2011
MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT
K103233 · LZO
Howmedica Osteonics Corp.
Orthopedic · 93d
Cleared Feb 03, 2011
OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS
K103309 · MAI
Smith & Nephew Endoscopy, Inc.
Orthopedic · 85d
Cleared Feb 03, 2011
INTERFUSE DA INVERTEBRAL BODY FUSION DEVICE
K110045 · MAX
Vertebral Technologies, Inc.
Orthopedic · 28d
Cleared Feb 02, 2011
SIGNATURE PLANNER
K102795 · JWH
Materialise NV
Orthopedic · 128d
Cleared Feb 02, 2011
TALON SPINAL SYSTEM
K102995 · MNI
Spine360
Orthopedic · 117d
Cleared Feb 02, 2011
POLARIS SPINAL SYSTEM
K103393 · KWQ
Biomet Spine
Orthopedic · 75d
Cleared Jan 31, 2011
PICCOLO COMPOSITE NAILING SYSTEM
K102369 · HSB
N.M.B. Medical Applications, Ltd.
Orthopedic · 164d
Cleared Jan 31, 2011
AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM
K102924 · KWS
Tornier, Inc.
Orthopedic · 123d
Cleared Jan 31, 2011
REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM
K103208 · PHX
Encore Medical, L.P.
Orthopedic · 91d
Cleared Jan 31, 2011
SMITH & NEPHEW SMF HIP STEM
K103256 · LPH
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Jan 28, 2011
LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS, LIMA-LTO SMR SHOULDER...
K101263 · KWT
Lima-Lto S.P.A.
Orthopedic · 268d