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
10681–10704 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 30, 2005
ENCORE CLP OFFSET TOTAL HIP SYSTEM
K052320 · KWA
Encore Medical Corporation
Orthopedic · 127d
Cleared Dec 28, 2005
ALLOCRAFT DBM
K052735 · MBP
Lifecell Corp.
Orthopedic · 89d
Cleared Dec 27, 2005
SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL
K052265 · NPJ
Smith & Nephew, Inc.
Orthopedic · 130d
Cleared Dec 27, 2005
TANGORS POLYAXIAL SYSTEM
K052385 · NKB
Ulrich GmbH & Co. KG
Orthopedic · 119d
Cleared Dec 27, 2005
ACUMATCH 12/14 C-SERIES CEMENTED FEMORAL STEMS (SIZE 1-6), ACUMATCH 12/14...
K052787 · LZO
Exactech, Inc.
Orthopedic · 85d
Cleared Dec 27, 2005
STRYKER COMPARTMENTAL KNEE SYSTEM
K052917 · NPJ
Howmedica Osteonics Corp.
Orthopedic · 71d
Cleared Dec 27, 2005
IST PEDICLE SCREW SYSTEM
K053276 · NKB
Innovative Spinal Technologies, Inc.
Orthopedic · 34d
Cleared Dec 22, 2005
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
K053051 · KTT
Vanguard Medical Concepts, Inc.
Orthopedic · 55d
Cleared Dec 22, 2005
NEXA BONE PLATE AND SCREW SYSTEM
K053408 · HRS
Nexa Orthopedics, Inc.
Orthopedic · 15d
Cleared Dec 21, 2005
SEASPINE VBR SYSTEM
K052170 · MQP
Seaspine, Inc.
Orthopedic · 134d
Cleared Dec 20, 2005
SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM
K052810 · MBI
Scandius Biomedical, Inc.
Orthopedic · 77d
Cleared Dec 19, 2005
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
K052906 · PHX
Zimmer, Inc.
Orthopedic · 66d
Cleared Dec 16, 2005
GRAFTON DBM
K051195 · MBP
Osteotech, Inc.
Orthopedic · 220d
Cleared Dec 16, 2005
MASTERGRAFT PUTTY BONE VOID FILLER
K051386 · MQV
Medtronic Vascular
Orthopedic · 203d
Cleared Dec 16, 2005
GRAFTCAGE TLX
K051781 · MQP
Osteotech, Inc.
Orthopedic · 168d
Cleared Dec 16, 2005
MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM
K052799 · MAI
Bonutti Research, Inc.
Orthopedic · 74d
Cleared Dec 16, 2005
STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH...
K052990 · KWY
Biomet, Inc.
Orthopedic · 53d
Cleared Dec 14, 2005
NEXA BONE SCREW SYSTEM
K053394 · HWC
Nexa Orthopedics, Inc.
Orthopedic · 8d
Cleared Dec 13, 2005
TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS...
K052776 · HTN
Arthrex, Inc.
Orthopedic · 71d
Cleared Dec 12, 2005
NUVASIVE COROENT EXTENSURE SYSTEM
K052210 · MQP
Nuvasive, Inc.
Orthopedic · 119d
Cleared Dec 12, 2005
CAPLESS PEDICLE SCREW SYSTEM
K052847 · MNI
X-Spine Systems, Inc.
Orthopedic · 66d
Cleared Dec 12, 2005
ARTHREX TENSIONLOK
K052901 · HRS
Arthrex, Inc.
Orthopedic · 59d
Cleared Dec 12, 2005
ORTHOFIX TITANIUM NAILING SYSTEMS
K053261 · HSB
Orthofix Srl
Orthopedic · 20d
Cleared Dec 09, 2005
LAGUNA MONOAXIAL PEDICLE SCREW SYSTEM
K051275 · NKB
Allez Spine, LLC
Orthopedic · 206d