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
11065–11088 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 27, 2005
ARTHREX BIO-PIN
K050259 · HTY
Arthrex, Inc.
Orthopedic · 113d
Cleared May 27, 2005
CO VERTEBRAL BODY REPLACEMENT
K050348 · MQP
Scient'X
Orthopedic · 105d
Cleared May 27, 2005
FORMAGRAFT COLLAGEN BONE GRAFT MATRIX
K050789 · MQV
R and D Medical, LLC
Orthopedic · 60d
Cleared May 27, 2005
PEEK CAS
K050861 · MQP
Interpore Cross Intl.
Orthopedic · 52d
Cleared May 27, 2005
MAXLOCK
K050868 · HRS
Orthohelix Surgical Designs, Inc.
Orthopedic · 51d
Cleared May 27, 2005
NEWDEAL ANKLE NAIL
K050882 · HSB
New Deal, S.A.
Orthopedic · 50d
Cleared May 27, 2005
MERETE DUOTHREADTM BONE SCREW
K050924 · HWC
Merete Medical GmbH
Orthopedic · 44d
Cleared May 27, 2005
ENCORE REVERSE SHOULDER PROSTHESIS
K051075 · PHX
Encore Medical, L.P.
Orthopedic · 30d
Cleared May 26, 2005
EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM
K050766 · HWE
Zimmer Trabecular
Orthopedic · 62d
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