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
13105–13128 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 07, 2000
EXTERNAL FIXATION ANCHOR PIN
K001228 · JDW
Immedica, Inc.
Orthopedic · 81d
Cleared Jul 07, 2000
SULZER ORTHOPEDICS INC. NATURAL-HIP SYSTEM LD STEM
K001320 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 72d
Cleared Jul 07, 2000
POROCOAT PRODIGY HIP PROSTHESIS
K001778 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 24d
Cleared Jul 05, 2000
IONICS LEVANTE INTERVERTEBRAL PILLAR, EXPANDABLE
K983667 · MQP
Ionics Medical Corp.
Orthopedic · 625d
Cleared Jun 29, 2000
SPINE SYSTEM EVOLUTION
K001080 · KWP
Aesculap, Inc.
Orthopedic · 86d
Cleared Jun 27, 2000
MODIFIED SINGLE AXLE TOTAL ELBOW
K000683 · JDC
Biomet, Inc.
Orthopedic · 119d
Cleared Jun 26, 2000
SMITH + NEPHEW RF ARTHROSCOPIC WAND SYSTEM
K001226 · HRX
Smith & Nephew, Inc.
Orthopedic · 70d
Cleared Jun 23, 2000
UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED
K000827 · KRR
Walter Abendschein, M.D.
Orthopedic · 101d
Cleared Jun 23, 2000
SULZER ORTHOPEDICS MS-30 FEMORAL STEM
K001078 · JDI
Sulzer Orthopedics, Inc.
Orthopedic · 80d
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