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
14521–14544 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 27, 1996
MODULAR ACETABULAR SHELL II
K955739 · LPH
Intermedics Orthopedics
Orthopedic · 100d
Cleared Mar 27, 1996
REFLECTION DUAL DIMENSION SHELL
K960094 · MBL
Smith & Nephew Richards, Inc.
Orthopedic · 76d
Cleared Mar 27, 1996
DEPUY POROCOAT HPS II HIP PROSTHESIS W/ARTICUL-EZE TAPER
K960172 · LPH
Depuy, Inc.
Orthopedic · 71d
Cleared Mar 27, 1996
STERILE KIRSCHNER WIRES AND STEINMANN PINS
K960385 · HTY
Depuy, Inc.
Orthopedic · 61d
Cleared Mar 27, 1996
OPTEON UNIPOLAR
K960538 · KWL
Exactech, Inc.
Orthopedic · 49d
Cleared Mar 25, 1996
K3 BONE SCREW SYSTEM
K960533 · HWC
Kinetikos Medical, Inc.
Orthopedic · 47d
Cleared Mar 25, 1996
K2 BONE SCREW SYSTEM
K960537 · HWC
Kinetikos Medical, Inc.
Orthopedic · 47d
Cleared Mar 22, 1996
NORTHO BONE SCREW
K925872 · HWC
Northo Orthopedics
Orthopedic · 1219d
Cleared Mar 22, 1996
SCHUHLI IMPLANT SYSTEM
K954963 · HRS
Synthes (Usa)
Orthopedic · 144d
Cleared Mar 22, 1996
HOWMEDICA ASYMMETRIC STEM FEMORAL COMPONENT
K955871 · LPH
Howmedica Corp.
Orthopedic · 87d
Cleared Mar 22, 1996
ALTA CFX IM ROD SYSTEM
K960524 · HSB
Howmedica Corp.
Orthopedic · 46d
Cleared Mar 21, 1996
INNOVASIVE 1.9MM ROC SUTURE BONE FASTENER
K954338 · MBI
Innovasive Devices, Inc.
Orthopedic · 185d
Cleared Mar 20, 1996
ORTHOFIX MODULSYSTEM
K955848 · JDW
Orthofix, Inc.
Orthopedic · 84d
Cleared Mar 20, 1996
HALL MODULAR ACETABULAR REAMER SYSTEM
K960852 · HWE
Linvatec Corp.
Orthopedic · 19d
Cleared Mar 18, 1996
PRACTIFIX EXTERNAL FIXATION SYSTEM
K960014 · KTT
Orthopaedic Innovations, Inc.
Orthopedic · 76d
Cleared Mar 18, 1996
KIRSHNER WIRES (K-WIRE) & STEINMANN PINS
K960023 · JDW
Promex, Inc.
Orthopedic · 76d
Cleared Mar 15, 1996
NEXGEN COMPLETE KNEE SOLUTION 9MM ARTICULAR SURFACE
K951185 · JWH
Zimmer, Inc.
Orthopedic · 365d
Cleared Mar 15, 1996
J.B. S. C1-C2 CLAMP
K955864 · KWP
J.B.S., S.A.
Orthopedic · 79d
Cleared Mar 15, 1996
CONSENSUS APEX DOME HOLE PLUG
K960340 · JDI
U.S. Medical Products, Inc.
Orthopedic · 51d
Cleared Mar 13, 1996
FREEMAN/SAMUELSON TOTAL KNEE SYSTEM
K943025 · JWH
Biomet, Inc.
Orthopedic · 625d
Cleared Mar 13, 1996
EBI ANTERIOR CERVICAL SPINE SYSTEM
K955730 · KWQ
Electro-Biology, Inc.
Orthopedic · 86d
Cleared Mar 13, 1996
TIBIA ORTHONAIL
K955761 · HSB
Orthologic Corp.
Orthopedic · 86d
Cleared Mar 13, 1996
COORDINATE REVISION KNEE SYSTEM
K955884 · JWH
Depuy, Inc.
Orthopedic · 76d
Cleared Mar 13, 1996
BRYAN POSTERIOR SPINAL FIXATOR (MODIFICATION)
K955927 · KWP
Arcan Orthopaedic Corp.
Orthopedic · 82d