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
11881–11904 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 06, 2003
MSD CABLE REDUCTION SYSTEM
K030816 · KWP
Medtronic Sofamor Danek
Orthopedic · 84d
Cleared Jun 06, 2003
PLUS ORTHOPEDICS CEMENTED HIP STEM
K031165 · JDI
Plus Orthopedics
Orthopedic · 53d
Cleared Jun 06, 2003
CUFFLOK ANCHOR
K031519 · MAI
Mitek Worldwide
Orthopedic · 22d
Cleared Jun 06, 2003
SYNTHES 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE
K031573 · KTT
Synthes (Usa)
Orthopedic · 17d
Cleared Jun 04, 2003
BIO-MODULAR SHOULDER SYSTEM
K030710 · KWT
Biomet, Inc.
Orthopedic · 90d
Cleared Jun 03, 2003
ALUMINA CERAMIC FEMORAL HEADS, 28 AND 32 MM
K030724 · LZO
Zimmer, Inc.
Orthopedic · 88d
Cleared Jun 02, 2003
PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX
K030848 · HWC
Karl Storz Endoscopy
Orthopedic · 77d
Cleared May 30, 2003
INION OTPS BIODEGRADABLE MINI PLATING SYSTEM
K023887 · HWC
Inion , Ltd.
Orthopedic · 190d
Cleared May 30, 2003
FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH)
K030972 · KWL
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 63d
Cleared May 30, 2003
EXOJET TISSUE MANAGEMENT SYSTEM
K031406 · HRX
Mitek Worldwide
Orthopedic · 25d
Cleared May 30, 2003
SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM
K031508 · JDQ
Synthes (Usa)
Orthopedic · 16d
Cleared May 28, 2003
ENCORE ANTERIOR SPINAL STAPLE SYSTEM
K030667 · KWQ
Encore Medical, L.P.
Orthopedic · 86d
Cleared May 28, 2003
MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)
K031219 · HSB
Orthofix, Inc.
Orthopedic · 41d
Cleared May 27, 2003
GENESIS II TOTAL KNEE SYSTEM
K030612 · MBH
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared May 23, 2003
GMRS PRESS FIT STEMS WITH PUREFIX HA
K031217 · LZO
Howmedica Osteonics
Orthopedic · 36d
Cleared May 22, 2003
HLS UNI EVOLUTION PROSTHESIS
K022211 · HSX
Tornier
Orthopedic · 318d
Cleared May 22, 2003
SMITH & NEPHEW PROFIX TOTAL KNEE SYSTEM
K030623 · MBH
Smith & Nephew, Inc.
Orthopedic · 84d
Cleared May 22, 2003
APEX MODULAR ACETABULAR CUP
K031110 · LPH
Apex Surgical, LLC
Orthopedic · 44d
Cleared May 22, 2003
TEXAS T - PLATE
K031334 · HRS
Biomet, Inc.
Orthopedic · 24d
Cleared May 22, 2003
CEMEX SYSTEM FAST
K031430 · LOD
Exactech, Inc.
Orthopedic · 16d
Cleared May 20, 2003
OSSATURA BCP BONE VOID FILLER
K030131 · MQV
Isotis NV
Orthopedic · 126d
Cleared May 20, 2003
CALLOS
K030554 · MQV
Skeletal Kinetics, LLC
Orthopedic · 88d
Cleared May 16, 2003
INTERPORE CROSS CEMENT RESTRICTOR
K023908 · JDK
Interpore Cross Intl.
Orthopedic · 172d
Cleared May 16, 2003
CD HORIZON SPINAL SYSTEM
K030932 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 52d