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
12049–12072 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
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
Cleared Jul 11, 2003
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1
K031823 · MQP
Implex Corp.
Orthopedic · 28d
Cleared Jul 10, 2003
EBI XFIX OPTIROM KNEE FIXATOR
K031093 · KTT
Ebi, L.P.
Orthopedic · 94d
Cleared Jul 08, 2003
SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM
K031555 · LXC
Synthes (Usa)
Orthopedic · 50d
Cleared Jul 02, 2003
SYNTHES ANTERIOR CERVICAL LOCKING PLATE (ACLP) SYSTEM
K031276 · KWQ
Synthes (Usa)
Orthopedic · 71d
Cleared Jul 01, 2003
TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318
K031685 · HWC
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Jul 01, 2003
GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS
K031734 · JDI
Biomet, Inc.
Orthopedic · 27d
Cleared Jul 01, 2003
DEPUY CERAMIC FEMORAL HEADS
K031803 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 20d
Cleared Jun 27, 2003
SMISSON STABILIZATION SYSTEM
K021979 · KWQ
Smisson-Cartledge
Orthopedic · 375d
Cleared Jun 27, 2003
ORIA CLARIS
K023378 · MNH
Ortho Tec, LLC
Orthopedic · 262d