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
11209–11232 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 26, 2005
XPAND CORPECTOMY SPACER
K050850 · MQP
Globus Medical, Inc.
Orthopedic · 52d
Cleared May 23, 2005
TITANIUM-HIP TOOL
K051032 · HRS
Orthopedic Sciences, Inc.
Orthopedic · 31d
Cleared May 23, 2005
POLYAXIAL HEMISPHERICAL SPINAL SCREWS
K051063 · MNI
Scient'X
Orthopedic · 27d
Cleared May 23, 2005
CUSTOM-HIP TOOL
K051181 · HRS
Orthopedic Sciences, Inc.
Orthopedic · 14d
Cleared May 19, 2005
FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE
K051000 · MQP
Spinal Concepts, Inc.
Orthopedic · 29d
Cleared May 18, 2005
BIOPRO TARA FEMORAL RESURFACING COMPONENT
K043542 · KXA
Biopro, Inc.
Orthopedic · 146d
Cleared May 18, 2005
PRECIMED CANNULATED SCREW SYSTEM
K050754 · HWC
Precimed, Inc.
Orthopedic · 56d
Cleared May 17, 2005
THEKEN REVEAL VBR SYSTEM
K050058 · MQP
Theken Surgical,Llc
Orthopedic · 126d
Cleared May 17, 2005
NEXGEN COMPLETE KNEE SOLUTION DISTAL FEMORAL SPACERS
K050105 · JDI
Zimmer, Inc.
Orthopedic · 119d
Cleared May 17, 2005
CD HORIZON SPINAL SYSTEM
K050981 · MNI
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared May 16, 2005
LANX SPINAL FIXATION SYSTEM
K043484 · MNI
Lanx, LLC
Orthopedic · 150d
Cleared May 16, 2005
DELTA HUMERAL CUPS
K050315 · PHX
DePuy Orthopaedics, Inc.
Orthopedic · 96d
Cleared May 12, 2005
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
K050471 · MNH
Solco Biomedical Co., Ltd.
Orthopedic · 78d
Cleared May 12, 2005
ARTHREX TAK FAMILY
K050749 · HWC
Arthrex, Inc.
Orthopedic · 50d
Cleared May 12, 2005
BASIS SPINAL SYSTEM
K051039 · KWQ
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 17d
Cleared May 12, 2005
ACUMED SCAPULA CONGRUENT BONE PLATE SYSTEM
K051083 · HRS
Acumed, LLC
Orthopedic · 15d
Cleared May 11, 2005
RADIOPAQUE BONE CEMENT
K043518 · NDN
Cardinalhealth
Orthopedic · 142d
Cleared May 11, 2005
ALUMINA HEAD
K050556 · LZO
Fournitures Hospitalieres Industrie
Orthopedic · 69d
Cleared May 11, 2005
HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM
K050892 · KWQ
Blackstone Medical, Inc.
Orthopedic · 33d
Cleared May 11, 2005
TRABECULAR METAL ACETABULAR REVISION SHELLS
K050937 · LPH
Zimmer Trabecular
Orthopedic · 27d
Cleared May 04, 2005
PROCOTYL-E ACETABULAR SYSTEM
K043073 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 177d
Cleared May 04, 2005
LAGUNA PEDICLE SCREW SYSTEM
K050060 · MNI
Allez Spine, LLC
Orthopedic · 113d
Cleared May 04, 2005
BASIS SPINAL SYSTEM
K050484 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 68d
Cleared May 04, 2005
ABC 2 SCREW
K050813 · KWQ
Aesculap, Inc.
Orthopedic · 34d