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
12025–12048 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 08, 2003
TWIN FIX AB 6.5 MM SUTURE ANCHOR, MODELS 720209, 7210210, 7210211, 7210212
K032197 · MAI
Smith & Nephew, Inc.
Orthopedic · 21d
Cleared Aug 08, 2003
VKS/TC-PLUS REVISION KNEE
K032215 · JWH
Plus Orthopedics
Orthopedic · 18d
Cleared Aug 08, 2003
BIORCI SCREW
K032224 · HWC
Smith & Nephew, Inc.
Orthopedic · 18d
Cleared Aug 08, 2003
GAMMA 3 NAIL SYSTEM
K032244 · HSB
Howmedica Osteonics Corp.
Orthopedic · 17d
Cleared Aug 08, 2003
MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM
K032264 · HSD
Howmedica Osteonics Corp.
Orthopedic · 16d
Cleared Aug 07, 2003
SPINAL CONCEPTS, INC. INFIX SYSTEM
K031672 · MQP
Spinal Concepts, Inc.
Orthopedic · 69d
Cleared Aug 06, 2003
EBI OMEGA21 SPINAL FIXATION SYSTEM
K031354 · MNI
Ebi, L.P.
Orthopedic · 99d
Cleared Aug 06, 2003
FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS)
K031401 · KTT
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 93d
Cleared Aug 06, 2003
THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS
K031462 · MBH
Implex Corp.
Orthopedic · 90d
Cleared Aug 06, 2003
MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA
K031693 · LPH
Biomet, Inc.
Orthopedic · 65d
Cleared Aug 04, 2003
BONESOURCE BVF
K031435 · MQV
Howmedica Osteonics
Orthopedic · 90d
Cleared Jul 31, 2003
GLOBAL MODULAR REPLACEMENT SYSTEM PEDIATRIC TIBIAL BEARING COMPONENT
K031480 · KRO
Howmedica Osteonics Corp.
Orthopedic · 80d
Cleared Jul 30, 2003
UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS
K031381 · MNI
Seaspine
Orthopedic · 90d
Cleared Jul 30, 2003
PEEK TETRIS SPINAL IMPLANT
K031757 · MQP
Signus Medical, LLC
Orthopedic · 54d
Cleared Jul 30, 2003
VERTE-STACK SPINAL SYSTEM
K031780 · MQP
Medtronic Sofamor Danek
Orthopedic · 50d
Cleared Jul 30, 2003
MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES
K032058 · KTT
Alliance Medical Corp.
Orthopedic · 28d
Cleared Jul 25, 2003
OXINIUM FEMORAL HEADS
K030766 · JDI
Smith & Nephew, Inc.
Orthopedic · 136d
Cleared Jul 25, 2003
STRYKER PLATING SYSTEM PERIARTICULAR PLATES
K031959 · LXT
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Jul 25, 2003
2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445
K031981 · MAI
Linvatec Biomaterials, Ltd.
Orthopedic · 29d
Cleared Jul 25, 2003
UC-PLUS SOLUTION UNICONDYLAR KNEE
K032052 · HRY
Plus Orthopedics
Orthopedic · 23d
Cleared Jul 25, 2003
MODIFICATION TO MACS MODULAR ANTERIOR CONSTRUCT SYSTEM
K032059 · KWQ
Aesculap, Inc.
Orthopedic · 23d
Cleared Jul 24, 2003
THERIFIL BONE FILLER
K031040 · MQV
Therics, Inc.
Orthopedic · 114d
Cleared Jul 24, 2003
MODIFICATION TO FORTITUDE CEMENT RESTRICTOR
K031837 · JDK
Spinal Concepts, Inc.
Orthopedic · 38d
Cleared Jul 24, 2003
HOFFMANN II COMPACT BALTIMORE COUPLING
K031941 · JEC
Howmedica Osteonics Corp.
Orthopedic · 30d