FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Orthopedic ×
17,985 results
12481–12504 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 24, 2002
REPROCESSED EXTERNAL FIXATION DEVICE
K012623 · KTT
Alliance Medical Corp.
Orthopedic · 315d
Cleared Jun 24, 2002
REPROCESSED EXTERNAL FIXATION DEVICE
K012634 · KTW
Alliance Medical, Inc.
Orthopedic · 315d
Cleared Jun 24, 2002
REPROCESSED EBI EXTERNAL FIXATION DEVICES
K012645 · KTW
Alliance Medical Corp.
Orthopedic · 315d
Cleared Jun 24, 2002
REPROCESSED HOWMEDICA EXTERNAL FIXATION DEVICES
K012648 · KTT
Alliance Medical Corp.
Orthopedic · 315d
Cleared Jun 21, 2002
RT-PLUS PE INSERT CLAMP
K021714 · KRO
Plus Orthopedics
Orthopedic · 28d
Cleared Jun 20, 2002
EQUATION FIXATION SYSTEM
K013962 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 199d
Cleared Jun 20, 2002
FOREX CORPORATION, OPTIMA, SPINAL SYSTEM
K020279 · MNI
Forex Corp.
Orthopedic · 143d
Cleared Jun 20, 2002
ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAIL
K021008 · HSB
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 84d
Cleared Jun 20, 2002
EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM
K021695 · KTT
Ebi, L.P.
Orthopedic · 29d
Cleared Jun 18, 2002
OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEM
K021009 · KWP
Spinal Concepts, Inc.
Orthopedic · 82d
Cleared Jun 12, 2002
SYNTHES 3.5 MM BROAD LC-DCP PLATES
K020872 · HRS
Synthes (Usa)
Orthopedic · 86d
Cleared Jun 12, 2002
ESOP CO-CR FEMORAL HEADS
K021109 · LPH
Fournitures Hospitalieres
Orthopedic · 68d
Cleared Jun 12, 2002
CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL
K021715 · LOD
Exactech, Inc.
Orthopedic · 20d
Cleared Jun 11, 2002
BIOSCREW XTRALOK
K013131 · HWC
Linvatec Corp.
Orthopedic · 265d
Cleared Jun 11, 2002
CALCIGEN-S BONE VOID FILER
K013790 · MQV
Biomet Orthopedics, Inc.
Orthopedic · 209d
Cleared Jun 11, 2002
RABEA CEMENT RESTRICTOR
K020836 · JDK
Signus Medical, LLC
Orthopedic · 89d
Cleared Jun 11, 2002
TOTAL HIP FEMORAL HEAD - 12/14 TAPER
K021673 · LZO
Smith & Nephew, Inc.
Orthopedic · 21d
Cleared Jun 06, 2002
HBS HEADLESS BONE SCREW
K020791 · HWC
Millennium Medical Technologies, Inc.
Orthopedic · 87d
Cleared Jun 06, 2002
SCORPIO INSET PATELLAR COMPONENT
K020830 · JWH
Howmedica Osteonics Corp.
Orthopedic · 84d
Cleared Jun 06, 2002
OSCAR, MODEL OE3000
K021502 · LZV
Orthosonics, Ltd.
Orthopedic · 28d
Cleared Jun 05, 2002
OMEGA II SYSTEM
K020772 · KTT
Howmedica Osteonics Corp.
Orthopedic · 89d
Cleared Jun 05, 2002
REDUCED SIZE ONCOLOGY SALVAGE SYSTEM
K021260 · KRO
Biomet, Inc.
Orthopedic · 47d
Cleared Jun 05, 2002
ASCENT ALL-POLY PS TIBIAL BEARINGS
K021559 · JWH
Biomet, Inc.
Orthopedic · 23d
Cleared Jun 05, 2002
FIXED BEARING UNI COMPONENT
K021621 · HRY
Biomet, Inc.
Orthopedic · 20d