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
14017–14040 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 06, 1998
PEBA ANCHOR/SUTURE COMBINATION
K972326 · MBI
Orthopaedic Biosystems, Ltd.
Orthopedic · 228d
Cleared Feb 06, 1998
UNI-ROM TOTAL HIP SYSTEM FEMORAL STEM
K974331 · LPH
Johnson & Johnson Professionals, Inc.
Orthopedic · 80d
Cleared Feb 04, 1998
AURORA TITANIUM SPINAL ROD SYSTEM
K974213 · MNH
United States Surgical, A Division of...
Orthopedic · 86d
Cleared Jan 30, 1998
MITEK ABSORBABLE POLYDIOXANONE (PDS) H FIX
K970119 · MBI
Mitek Products
Orthopedic · 381d
Cleared Jan 30, 1998
XPS STRAIGHTSHOT MICROBRIDER SYSTEM OR TREBAY SHAVER SYSTEM
K973499 · HRX
Xomed, Inc.
Orthopedic · 136d
Cleared Jan 30, 1998
CRANIOFACIAL ANCHORS
K974136 · MBI
Biomet, Inc.
Orthopedic · 88d
Cleared Jan 30, 1998
LACTOSORB PANELS
K974309 · HRS
Biomet, Inc.
Orthopedic · 74d
Cleared Jan 30, 1998
ADVANCE TOTAL KNEE SYSTEM
K974328 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 73d
Cleared Jan 28, 1998
FOUNDATION POROUS ACETABULAR SYSTEM
K973119 · LPH
Encore Orthopedics, Inc.
Orthopedic · 161d
Cleared Jan 28, 1998
FOUNDATION POROUS COATED HEMISPHERICAL SHELL
K974093 · LPH
Encore Orthopedics, Inc.
Orthopedic · 90d
Cleared Jan 28, 1998
FOUNDATION POROUS COATED FLARED RIM SHELL
K974095 · LPH
Encore Orthopedics, Inc.
Orthopedic · 90d
Cleared Jan 23, 1998
ULTIMATE COMPRESSION SCREW SYSTEM
K972722 · HWC
Orthopedic Designs, Inc.
Orthopedic · 186d
Cleared Jan 22, 1998
GLOBAL TOTAL SHOULDER ECCENTRIC HUMERAL HEAD
K974044 · KWS
DePuy Orthopaedics, Inc.
Orthopedic · 90d
Cleared Jan 21, 1998
DEPUY AMK 3 PEG PATELLA
K972643 · JWH
Depuy, Inc.
Orthopedic · 190d
Cleared Jan 21, 1998
CARPAL ENGAGING WRIST FUSION PLATE
K974030 · HRS
Terray Corp.
Orthopedic · 90d
Cleared Jan 16, 1998
OSTEONICS SCORPIO TOTAL KNEE UNIVERSAL DOME PATELLAR COMPONENT
K972967 · JWH
Osteonics Corp.
Orthopedic · 158d
Cleared Jan 16, 1998
VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW
K973309 · HWC
Vilex, Inc.
Orthopedic · 135d
Cleared Jan 16, 1998
TIMESH SYSTEM
K974017 · HRS
Sofamor Danek USA,Inc.
Orthopedic · 86d
Cleared Jan 13, 1998
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
K973923 · KWQ
Ebi Electro Biology
Orthopedic · 90d
Cleared Jan 12, 1998
ENCORE LINEAR HIP
K972791 · JDI
Encore Orthopedics, Inc.
Orthopedic · 168d
Cleared Jan 12, 1998
ORBITAL RECONSTRUCTION PLATES
K973982 · HRS
Howmedica, Inc.
Orthopedic · 84d
Cleared Jan 12, 1998
ENCORE LINEAR POROUS COATED HIP
K974294 · LPH
Encore Orthopedics, Inc.
Orthopedic · 59d
Cleared Jan 12, 1998
OSTEONICS SERIES 7000 TOTAL KNEE ANTERIOR FEMORAL BLOCKS
K974434 · HRY
Osteonics Corp.
Orthopedic · 49d
Cleared Jan 08, 1998
SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)
K973868 · KWP
Osteotech, Inc.
Orthopedic · 90d