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
14305–14328 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
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
Cleared Mar 14, 1997
ISOLA TWISTER CONNECTOR
K965046 · MNH
Acromed Corp.
Orthopedic · 86d
Cleared Mar 13, 1997
TRUE/FIT FEMORAL INTRAMEDULLARY ROD SYSTEM
K961360 · HSB
Encore Orthopedics, Inc.
Orthopedic · 338d
Cleared Mar 13, 1997
IMPLEX REPLACEMENT ACETABULAR CUP INSERT
K964882 · LPH
Implex Corp.
Orthopedic · 98d
Cleared Mar 13, 1997
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
K965145 · KWP
Depuy, Inc.
Orthopedic · 80d
Cleared Mar 13, 1997
HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR
K965164 · LPH
Howmedica Corp.
Orthopedic · 79d
Cleared Mar 13, 1997
HOWMEDICA MAINSTAY ANCHOR
K965175 · JDR
Howmedica Corp.
Orthopedic · 79d
Cleared Mar 13, 1997
BIORIGID NAIL TIBIA
K970013 · HTY
Aap GmbH and Co. Betriebs KG
Orthopedic · 70d
Cleared Mar 13, 1997
LINK CERCLAGE WIRE SYSTEM
K970084 · JDQ
Turnkey Intergration USA, Inc.
Orthopedic · 63d
Cleared Mar 13, 1997
PROXIMAL FEMORAL NAIL (PFN) SYSTEM
K970097 · JDW
Synthes (Usa)
Orthopedic · 59d