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
13249–13272 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 23, 2000
TRIFLANGE ACETABULAR CUP SYSTEM
K001277 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 63d
Cleared Jun 22, 2000
ANATOMIC TOTAL KNEE PROSTHESIS
K000978 · JWH
Biomet, Inc.
Orthopedic · 87d
Cleared Jun 22, 2000
CD HORIZON ECLIPSE
K001066 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 80d
Cleared Jun 22, 2000
AEQUALIS UNIVERSAL SHOULDER GLENOID
K994393 · KWS
Tornier
Orthopedic · 177d
Cleared Jun 20, 2000
SYNTHES (USA) ORIBITAL MESH PLATES
K001311 · HRS
Synthes (Usa)
Orthopedic · 56d
Cleared Jun 20, 2000
CALCIUM SULFATE PELLETS
K001559 · MQV
Howmedica Osteonics Corp.
Orthopedic · 32d
Cleared Jun 20, 2000
ALLEN MEDULLARY CEMENT PLUGS, ZIMMER POLY PLUG INTRAMEDULLARY SYSTEM, MODEL...
K001733 · JDI
Zimmer, Inc.
Orthopedic · 13d
Cleared Jun 19, 2000
ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM
K994239 · KWQ
Medtronic Sofamor Danek, Inc.
Orthopedic · 186d
Cleared Jun 16, 2000
SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS
K000972 · LXT
Synthes (Usa)
Orthopedic · 81d
Cleared Jun 16, 2000
DYNA-LOK CLASSIC SPINAL SYSTEM
K001532 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 30d
Cleared Jun 15, 2000
THE IMPLEX HEDROCEL MODULAR ELLIPTICAL ACETABULAR CUP
K001039 · LPH
Implex Corp.
Orthopedic · 76d
Cleared Jun 15, 2000
TRANS FX ADJUSTABLE PIN TO BAR CLAMP
K001084 · LXT
Immedica, Inc.
Orthopedic · 72d
Cleared Jun 14, 2000
MICROPERFORATION INSTRUMENT
K001507 · LXH
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Jun 14, 2000
MALLORY HEAD MODULAR CALCAR
K001660 · LPH
Biomet Orthopedics, Inc.
Orthopedic · 14d
Cleared Jun 12, 2000
PINNACLE ACETABULAR SYSTEM
K001534 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 26d
Cleared Jun 12, 2000
SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM
K993335 · HTO
Synthes (Usa)
Orthopedic · 252d
Cleared Jun 08, 2000
OMEGA II MODULAR TOTAL HIP SYSTEM
K000817 · JDI
Osteoimplant Technology, Inc.
Orthopedic · 87d
Cleared Jun 08, 2000
BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS
K001046 · KWS
Biopro, Inc.
Orthopedic · 69d
Cleared Jun 07, 2000
MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS
K001548 · KRO
Howmedica Osteonics Corp.
Orthopedic · 20d
Cleared Jun 07, 2000
WINDOW CERVICAL DYNAMIC PLATE SYSTEM
K993066 · KWQ
Advanced Spine Technology, Inc.
Orthopedic · 349d
Cleared Jun 05, 2000
BOFOR REVISION COUP
K993874 · LZO
Plus Orthopedics
Orthopedic · 203d
Cleared Jun 03, 2000
TRIFIX SPINAL FIXATION SYSTEM
K001627 · MNH
Endius, Inc.
Orthopedic · 8d
Cleared Jun 01, 2000
TRI-FIX SPINAL FIXATION SYSTEM
K000766 · MNI
Endius, Inc.
Orthopedic · 84d
Cleared May 23, 2000
REACH FEMORAL COMPONENT
K000760 · LPH
Biomet, Inc.
Orthopedic · 76d