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
14161–14184 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Apr 07, 1997
RIWO DRIVE WITH FOOTSWITCH/MOTOR HANDLE, COOMPLETE,6000RPM/3000RPM/ROTARY...
K970088 · HWE
Richard Wolf Medical Instruments Corp.
Orthopedic · 87d
Cleared Apr 03, 1997
ATLAS III ACETABULAR CUP
K961388 · MEH
Fournitures Hospitalieres
Orthopedic · 358d
Cleared Apr 03, 1997
BIOMET BONE SCREW
K964970 · HWC
Biomet, Inc.
Orthopedic · 112d
Cleared Apr 03, 1997
ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM
K970462 · KWQ
Acromed Corp.
Orthopedic · 56d
Cleared Apr 03, 1997
COMPASS UNIVERSAL HINGE
K970713 · JDW
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 35d
Cleared Apr 02, 1997
KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAY
K961260 · HSD
Biomet, Inc.
Orthopedic · 365d
Cleared Apr 02, 1997
FOUNDATION KNEE SYSTEM TIBIAL COMPONENT
K970031 · JWH
Encore Orthopedics, Inc.
Orthopedic · 89d
Cleared Apr 02, 1997
SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEM
K970733 · HTY
Synthes (Usa)
Orthopedic · 33d
Cleared Apr 01, 1997
EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEM
K970290 · KTT
Ebi, L.P.
Orthopedic · 67d
Cleared Mar 26, 1997
DEPUY MOTECH TITANIUM MOSS MIAMI SPINAL SYSTEM
K964024 · KWP
Depuy, Inc.
Orthopedic · 170d
Cleared Mar 26, 1997
BACFIX SPINAL FIXATION SYSTEM
K964404 · KWP
Spinal Concepts, Inc.
Orthopedic · 142d
Cleared Mar 25, 1997
SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM
K963325 · HRS
Synthes (Usa)
Orthopedic · 214d
Cleared Mar 25, 1997
AVANTA ORTHOPAEDICS TENDON SPACER
K964359 · HXA
Avanta Orthopaedics, Inc.
Orthopedic · 144d
Cleared Mar 25, 1997
THE C-FIT FEMORAL HIP SYSTEM
K965019 · JDI
Corin USA
Orthopedic · 99d
Cleared Mar 25, 1997
FIXATION PIN OR ROD
K970036 · HTY
United States Surgical, A Division of...
Orthopedic · 81d
Cleared Mar 25, 1997
INNOVASIVE 2.8MM AND 3.5MM ROC LF SUTURE BONE FASTENER
K970089 · MBI
Innovasive Devices, Inc.
Orthopedic · 74d
Cleared Mar 24, 1997
WRIGHT PLASTER OF PARIS BONE VOID FILLER KIT (SUBJECT TO REVISION)
K963587 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 196d
Cleared Mar 21, 1997
METAGEN ALL POLY ACETABULAR CUP SYSTEM
K964003 · JDI
Metagen, LLC
Orthopedic · 165d
Cleared Mar 21, 1997
DEPUY ACE AIM TITANIUM TIBIAL NAIL
K970202 · HSB
Depuy Ace Medical Co.
Orthopedic · 59d
Cleared Mar 18, 1997
MOSS MIAMI SPINAL SYSTEM
K962628 · KWP
Depuy, Inc.
Orthopedic · 256d
Cleared Mar 17, 1997
KIRSCHNER KNEE MODIFIED
K961021 · JWH
Biomet, Inc.
Orthopedic · 368d
Cleared Mar 17, 1997
SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD...
K964416 · KWQ
Synthes (Usa)
Orthopedic · 164d
Cleared Mar 17, 1997
ACUMED SUTURE WASHER
K965028 · HTN
Acu Med, Inc.
Orthopedic · 90d
Cleared Mar 17, 1997
LIBERTY ANTERIOR SPINAL SYSTEM
K965193 · KWQ
Sofamor Danek USA,Inc.
Orthopedic · 83d