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
11113–11136 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 10, 2005
OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE
K043420 · MQV
Regeneration Technologies, Inc.
Orthopedic · 59d
Cleared Feb 10, 2005
CD HORIZON SPINAL SYSTEM
K050079 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared Feb 09, 2005
SCORPIO NRG KNEE SYSTEM
K042343 · JWH
Howmedica Osteonics Corp.
Orthopedic · 163d
Cleared Feb 09, 2005
DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM
K043505 · KWT
Biomet, Inc.
Orthopedic · 51d
Cleared Feb 07, 2005
ATALIA TITANIUM SURGICAL MESH
K041798 · MQP
Us Spinal Technologies, LLC
Orthopedic · 220d
Cleared Feb 07, 2005
OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
K042073 · KWQ
Olsen Medical
Orthopedic · 189d
Cleared Feb 07, 2005
STEALTH FUSION SYSTEM, MODEL RR 1000
K043174 · KTT
R&R Medical, Inc.
Orthopedic · 83d
Cleared Feb 07, 2005
RABEA SPINAL IMPLANT
K043316 · MQP
Signus Medizintechnik GmbH
Orthopedic · 67d
Cleared Feb 07, 2005
NUVASIVE COROENT SYSTEM
K043405 · MQP
Nuvasive, Inc.
Orthopedic · 59d
Cleared Feb 03, 2005
PIONEER ANTERIOR CERVICAL PLATE SYSTEM
K043066 · KWQ
Pioneer Surgical Technology
Orthopedic · 87d
Cleared Feb 03, 2005
SYNTHES 3.5MM CORTEX SCREWS
K043185 · HWC
Synthes (Usa)
Orthopedic · 78d
Cleared Feb 03, 2005
SIGN FIN NAIL
K043200 · HSB
Surgical Implant Generation Network...
Orthopedic · 77d
Cleared Feb 03, 2005
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K043321 · NKB
Medtronic Sofamor Danek
Orthopedic · 63d
Cleared Feb 03, 2005
NANOSS BONE VOID FILLER
K050025 · MQV
Angstrom Medica, Inc.
Orthopedic · 28d
Cleared Feb 01, 2005
GAPP GRAFT CONTIANMENT DEVICE ORTHOPEDICS
K031782 · KWQ
Medtronic Sofamor Danek
Orthopedic · 602d
Cleared Feb 01, 2005
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K043151 · KWQ
Medtronic Sofamor Danek
Orthopedic · 78d
Cleared Feb 01, 2005
VERTEBRON PSS PEDICLE SCREW SYSTEM
K043152 · MNH
Vertebron, Inc.
Orthopedic · 78d
Cleared Feb 01, 2005
GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL
K043233 · HSB
Efratgo, Ltd. HI Tech Bio-Surgical
Orthopedic · 71d
Cleared Jan 31, 2005
SIRUS INTRAMEDULLARY NAIL-FEMORAL AND TIBIAL NAILS, MODELS 02.02631,...
K043270 · HSB
Zimmer GmbH
Orthopedic · 66d
Cleared Jan 31, 2005
GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00
K043346 · KWS
Genesis Medical LLC
Orthopedic · 56d
Cleared Jan 31, 2005
ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM, MODEL 2357 & 2359
K050121 · HRS
Zimmer, Inc.
Orthopedic · 12d
Cleared Jan 28, 2005
MOSAIC NON-MODULAR PROXIMAL BODY AND EAS OFFSET MODULAR HUMERAL HEAD
K042321 · KWT
Biomet Manufacturing Corp
Orthopedic · 155d
Cleared Jan 27, 2005
SOLITUDE UNIPOLAR HEAD
K042973 · KWL
Ortho Development Corp.
Orthopedic · 91d
Cleared Jan 26, 2005
DISTAL RADIO-ULNAR JOINT IMPLANT
K040497 · KXE
Aptis Medical, LLC
Orthopedic · 335d