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
9793–9816 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 18, 2007
CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM
K072537 · MQP
Creaspine Sas
Orthopedic · 99d
Cleared Dec 17, 2007
METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS
K071679 · HSB
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 181d
Cleared Dec 17, 2007
CROSS.BONE
K071876 · MQV
TriMed, Inc.
Orthopedic · 164d
Cleared Dec 17, 2007
SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM
K073186 · HRS
Synthes (Usa)
Orthopedic · 34d
Cleared Dec 14, 2007
FOUNDATION (FMP) POROUS COATED SPIKED ACETABULAR SYSTEM
K072154 · LPH
Encore Medical, L.P.
Orthopedic · 133d
Cleared Dec 14, 2007
ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM
K072832 · HRS
DePuy Orthopaedics, Inc.
Orthopedic · 72d
Cleared Dec 13, 2007
ISSYS LP SPINAL FIXATION SYSTEM
K072866 · KWP
Custom Spine, Inc.
Orthopedic · 69d
Cleared Dec 13, 2007
BEACON STABILIZATION SYSTEM
K073172 · NKB
Globus Medical, Inc.
Orthopedic · 30d
Cleared Dec 12, 2007
COMPREHENSIVE RS SHOULDER SYSTEM
K072804 · PHX
Biomet Manufacturing Corp
Orthopedic · 72d
Cleared Dec 12, 2007
MODIFICATION TO:MAKO SURGICAL UNICONDYLAR KNEE SYSTEM
K073248 · HSX
Mako Surgical Corp.
Orthopedic · 23d
Cleared Dec 11, 2007
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K071942 · KWP
Medtronic Sofamor Danek
Orthopedic · 151d
Cleared Dec 10, 2007
IMPIX SPACER
K072226 · MAX
Medicrea Technologies
Orthopedic · 122d
Cleared Dec 10, 2007
TWINFIX FT PK
K072785 · HWC
Smith & Nephew Inc., Endoscopy Division
Orthopedic · 70d
Cleared Dec 07, 2007
ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0
K070021 · HRX
Jg Medical Products, LLC
Orthopedic · 338d
Cleared Dec 07, 2007
STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT
K072118 · NDN
Stryker Corp.
Orthopedic · 128d
Cleared Dec 07, 2007
ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
K072840 · NKB
Endius, Inc.
Orthopedic · 64d
Cleared Dec 07, 2007
CINCH KNOTLESS FIXATION IMPLANT SYSTEM
K073226 · MBI
C2m Medical, Inc.
Orthopedic · 22d
Cleared Dec 06, 2007
LEGION STEM WITH HOLES
K072531 · JWH
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Dec 06, 2007
EXPEDIUM SPINE SYSTEM
K073126 · NKB
Depuy Spine, Inc.
Orthopedic · 30d
Cleared Dec 06, 2007
MANTIS SPINAL SYSTEM
K073151 · NKB
Stryker Corp.
Orthopedic · 28d
Cleared Dec 05, 2007
VALEO VBR
K073125 · MQP
Amedica Corp.
Orthopedic · 29d
Cleared Dec 04, 2007
NUVASIVE COROENT SYSTEM
K071795 · MAX
Nuvasive, Inc.
Orthopedic · 155d
Cleared Dec 04, 2007
MEMOMETAL BONE ANCHORS
K071941 · HWC
Memometal Technologies
Orthopedic · 144d
Cleared Nov 30, 2007
COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT
K070015 · LOD
Biomet Manufacturing Corp
Orthopedic · 331d