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
11905–11928 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
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
Cleared Jul 22, 2003
EBI SPINELINK - II SPINAL FIXATION SYSTEM
K031355 · NKB
Ebi, L.P.
Orthopedic · 84d
Cleared Jul 22, 2003
EBI SPINELINK SPINAL FIXATION SYSTEM
K031424 · NKB
Ebi, L.P.
Orthopedic · 77d
Cleared Jul 17, 2003
SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM
K030087 · NKB
Spinal Concepts, Inc.
Orthopedic · 189d
Cleared Jul 17, 2003
POLYGRAFT BONE GRAFT SUBSTITUTE
K030288 · MQV
Osteobiologics, Inc.
Orthopedic · 170d
Cleared Jul 17, 2003
OSTEO-G BONE VOID FILLER SYSTEM
K031319 · MQV
Aspine USA, Inc.
Orthopedic · 83d
Cleared Jul 17, 2003
ACUMED SMALL BONE LOCKING ROD SYSTEM II
K031438 · HSB
Acumed, LLC
Orthopedic · 72d
Cleared Jul 17, 2003
CELLPLEX TCP SYNTHETIC CANCELLOUS BONE
K031817 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 35d
Cleared Jul 17, 2003
XIA SPINAL SYSTEM AND XIA STAINLESS STEEL SYSTEM
K031893 · KWP
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Jul 15, 2003
ORTHO DEVELOPMENT BALANCED KNEE MODULAR TIBIAL SYSTEM
K031201 · JWH
Ortho Development Corp.
Orthopedic · 90d
Cleared Jul 14, 2003
PCW PERCUTANEOUS COMPRESSION WIRE
K031050 · HWC
Millennium Medical Technologies, Inc.
Orthopedic · 103d
Cleared Jul 14, 2003
EXTERNAL FIXATION SYSTEMS
K031181 · KTT
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Jul 14, 2003
TIBIAL SPACER FOR THE NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE
K031183 · JWH
Centerpulse Orthopedics, Inc.
Orthopedic · 90d
Cleared Jul 14, 2003
BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST
K031203 · JWJ
DePuy Orthopaedics, Inc.
Orthopedic · 89d
Cleared Jul 14, 2003
SYNTHES SMALL COBINATION CLAMP-MR SAFE
K031724 · KTT
Synthes (Usa)
Orthopedic · 41d
Cleared Jul 12, 2003
SPINAL CONCEPTS, INC. CADENCE AND FORTITUDE
K031914 · MQP
Spinal Concepts, Inc.
Orthopedic · 22d