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
11905–11928 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 16, 2003
MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS
K031218 · JDB
Tornier
Orthopedic · 29d
Cleared May 15, 2003
MODIFICATION TO HORIZON SPINAL SYSTEM
K030840 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 59d
Cleared May 13, 2003
MODIFICATION TO EASYS TRANSVERSE CONNECTION
K031290 · MNH
Scient'X USA, Inc.
Orthopedic · 20d
Cleared May 06, 2003
SURGICAL SIMPLEX P WITH TOBRAMYCIN
K014199 · LOD
Howmedica Osteonics Corp.
Orthopedic · 501d
Cleared May 05, 2003
ADHOC CLAW
K023963 · MBI
Future Medical Systems, Inc.
Orthopedic · 157d
Cleared May 05, 2003
SYNTHES (USA) 3.5 MM BROAD LCP & 4.5 MM LCP DISTAL HUMERUS PLATES
K031178 · HRS
Synthes (Usa)
Orthopedic · 21d
Cleared May 01, 2003
MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 8026 SERIES
K030733 · LPH
Zimmer, Inc.
Orthopedic · 52d
Cleared May 01, 2003
SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM
K031162 · JDQ
Smith & Nephew, Inc.
Orthopedic · 17d
Cleared Apr 28, 2003
ORTHOPEDIC WIRE
K031127 · JDR
Howmedica Osteonics Corp.
Orthopedic · 19d
Cleared Apr 24, 2003
AMATOMICAL SHOULDER WITH REMOVABLE HEAD
K030259 · KWS
Centerplus Orthopedics, Inc.
Orthopedic · 90d
Cleared Apr 24, 2003
IMPACT SUTURE ANCHOR. MODEL 433510
K030388 · HWC
Bionx Implants, Ltd.
Orthopedic · 78d
Cleared Apr 24, 2003
BLACKSTONE FUSION ANTERIOR CERVICAL PLATING SYSTEM
K030595 · KWQ
Blackstone Medical, Inc.
Orthopedic · 58d
Cleared Apr 24, 2003
MODIFICATION TO MODULAR PLUS REVISION STEM
K030971 · LWJ
Plus Orthopedics
Orthopedic · 27d
Cleared Apr 24, 2003
MODIFICATION TO DEPUY SOLUTION SYSTEM HIP PROSTHESIS
K030979 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 27d
Cleared Apr 24, 2003
MODIFICATION TO XIA STAINLESS STEEL SYSTEM
K031090 · KWP
Howmedica Osteonics Corp.
Orthopedic · 17d
Cleared Apr 22, 2003
MASTERGRAFT MATRIX
K023553 · MQV
Medtronic Sofamor Danek, Inc.
Orthopedic · 181d
Cleared Apr 22, 2003
SYNTHES STAINLESS STEEL MODULAR HAND SYSTEM
K030310 · HRS
Synthes (Usa)
Orthopedic · 82d
Cleared Apr 18, 2003
LEFORTE SYSTEM BONE SCREW
K023365 · HWC
Jeil Medical Corporation
Orthopedic · 193d
Cleared Apr 18, 2003
MODIFIED VERTE-STACK SPINAL SYSTEM
K030735 · MQP
Medtronic Sofamor Danek
Orthopedic · 39d
Cleared Apr 18, 2003
SYNTHES ANTERIOR CSLP SYSTEM
K030866 · KWQ
Synthes (Usa)
Orthopedic · 30d
Cleared Apr 17, 2003
ARTHROSCOPY PUMP, MODEL A107
K030402 · HRX
W.O.M. World of Medicine AG
Orthopedic · 70d
Cleared Apr 17, 2003
BLACKSTONE SPINAL FIXATION SYSTEM RIGID CROSS CONNECTOR
K030862 · MNI
Blackstone Medical, Inc.
Orthopedic · 30d
Cleared Apr 10, 2003
CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM
K023096 · HSD
Std Mfg., Inc.
Orthopedic · 204d
Cleared Apr 10, 2003
CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM
K030151 · LZO
Hayes Medical, Inc.
Orthopedic · 85d