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
6961–6984 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 11, 2013
CERTEX OCT SPINAL IMPLANT SYSTEM
K133094 · KWP
X-Spine Systems, Inc.
Orthopedic · 72d
Cleared Dec 11, 2013
CLYDESDALE SPINAL SYSTEM
K132897 · MAX
Medtronic Sofamor Danek, Inc.
Orthopedic · 86d
Cleared Dec 11, 2013
VANGUARD XP KNEE SYSTEM
K132873 · MBH
Biomet, Inc.
Orthopedic · 89d
Cleared Dec 11, 2013
SMITH & NEPHEW PATIENT MATCHED CUTTING BLOCKS
K130708 · JWH
Smith & Nephew, Inc.
Orthopedic · 271d
Cleared Dec 11, 2013
GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEM
K130317 · ODP
Genesys Spine
Orthopedic · 306d
Cleared Dec 10, 2013
RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM
K133039 · NPJ
Mako Surgical Corporation
Orthopedic · 75d
Cleared Dec 09, 2013
PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
K133289 · HSB
Ellipse Technologies, Inc.
Orthopedic · 45d
Cleared Dec 09, 2013
K7 LUMBAR SPACERS
K133126 · MAX
K7, LLC
Orthopedic · 70d
Cleared Dec 09, 2013
EXOSHAPE DUO SOFT TISSUE FASTENER
K132783 · MBI
MedShape, Inc.
Orthopedic · 94d
Cleared CT Dec 06, 2013
CROSSTREES PVA POD
K133372 · NDN
Crosstrees Medical, Inc.
Orthopedic · 35d
Cleared Dec 06, 2013
STAXX(R) SYSTEM
K133207 · MQP
Spine Wave, Inc.
Orthopedic · 49d
Cleared Dec 06, 2013
LIGAPASS
K132395 · OWI
Medicrea International
Orthopedic · 127d
Cleared Dec 06, 2013
CD HORIZON SPINAL SYSTEM
K132328 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 133d
Cleared Dec 05, 2013
AEQUALIS HUMERAL NAIL
K133376 · HSB
Tornier, Inc.
Orthopedic · 31d
Cleared Dec 05, 2013
ANODYNE ANTERIOR CERVICAL PLATE SYSTEM
K132994 · KWQ
Corelink, LLC
Orthopedic · 72d
Cleared Dec 05, 2013
IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
K132640 · HSX
Conformis, Inc.
Orthopedic · 104d
Cleared Dec 05, 2013
AEQUALIS REVERSED SHOULDER PROSTHESIS
K132285 · PHX
Tornier S.A.S.
Orthopedic · 135d
Cleared Dec 05, 2013
POROUS MORPHIX SUTURE ANCHOR WITH FORCE FIBER SUTURE
K130467 · MBI
MedShape, Inc.
Orthopedic · 283d
Cleared Dec 04, 2013
PERIMETER C SPINAL SYSTEM
K132584 · ODP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 110d
Cleared Dec 02, 2013
1ST MTP PLATE
K133437 · HRS
Osteomed
Orthopedic · 25d
Cleared Nov 29, 2013
PIEZOSURGERY FLEX
K132848 · JDX
Mectron S.P.A.
Orthopedic · 79d
Cleared Nov 27, 2013
ZIP MIS INTERSPINOUS FUSION SYSTEM
K133091 · PEK
Aurora Spine
Orthopedic · 58d
Cleared Nov 27, 2013
TITLE 2 POLYAXIAL SPINAL SYSTEM
K133086 · NKB
Zimmer Spine, Inc.
Orthopedic · 58d
Cleared Nov 27, 2013
ESPIN SYSTEM
K133061 · HRX
Nlt Spine, Ltd.
Orthopedic · 61d