FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,850 results
11209–11232 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
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
Cleared Jan 26, 2005
CHARLOTTE SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003
K043583 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 29d
Cleared Jan 25, 2005
Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED
K040685 · LWJ
Osteoimplant Technology, Inc.
Orthopedic · 315d
Cleared Jan 25, 2005
EQUESTRA FLUID DELIVERY SYSTEM
K043568 · HRX
Medtronic Sofamor Danek
Orthopedic · 29d
Cleared Jan 21, 2005
MALLORY-HEAD MODULAR CALCAR STEMS WITH INTERLOCKING SLOTS
K042774 · LPH
Biomet, Inc.
Orthopedic · 108d
Cleared Jan 21, 2005
MULTI-USE COMPRESSION SCREW
K043102 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 73d
Cleared Jan 21, 2005
TEMPFIX EXTERNAL FIXATION SYSTEM, MR SAFE
K043113 · KTT
DePuy Orthopaedics, Inc.
Orthopedic · 72d
Cleared Jan 21, 2005
PIONEER VERTEBRAL BODY REPLACEMENT DEVICE (PIONEER VERTEBRAL SPACER)
K043206 · MQP
Pioneer Surgical Technology
Orthopedic · 63d
Cleared Jan 21, 2005
ALLOGRAN-N-BONE VOID FILLER
K043514 · MQV
Biocomposites, Ltd.
Orthopedic · 32d
Cleared Jan 21, 2005
PERIARTICULAR LOCKING PLATES AND SCREWS, SERIES 2358 AND 2359
K043560 · HRS
Zimmer, Inc.
Orthopedic · 25d
Cleared Jan 19, 2005
PINN-ACL CROSSPIN
K043106 · HTY
Linvatec Corp.
Orthopedic · 71d
Cleared Jan 19, 2005
CHARLOTTE HIGH-DEMAND COMPRESSION SCREW
K043281 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 54d
Cleared Jan 18, 2005
SYNTHES (USA) EXTERNAL FIXATION COMPONENT LINE EXTENSION - MR SAFE
K043039 · KTT
Synthes (Usa)
Orthopedic · 75d