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
12937–12960 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 25, 2001
END-TO-END AND SIDE-BY-SIDE CONNECTORS
K010563 · MNI
Spinal Concepts, Inc.
Orthopedic · 88d
Cleared May 24, 2001
TC-PLUS POROUS FEMORAL COMPONENTS
K011258 · JWH
Plus Orthopedics
Orthopedic · 30d
Cleared May 24, 2001
TC-PLUS POROUS TIBIAL COMPONENTS
K011288 · JWH
Plus Orthopedics
Orthopedic · 27d
Cleared May 23, 2001
WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL...
K003618 · NDD
Whiteside Biomechanics, Inc.
Orthopedic · 182d
Cleared May 23, 2001
SYNTHES ANTEROLATERAL CALCANEAL PLATE
K010518 · KTT
Synthes (Usa)
Orthopedic · 90d
Cleared May 23, 2001
ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM
K010525 · HWC
Arthrex, Inc.
Orthopedic · 90d
Cleared May 23, 2001
MONARCH SPINE SYSTEM
K010576 · MNI
Depuyacromed
Orthopedic · 85d
Cleared May 23, 2001
LACTOSORB PLATES, MESHES, AND PANELS/SHEETS
K011237 · HRS
Biomet, Inc.
Orthopedic · 30d
Cleared May 18, 2001
ASCENT KNEE SYSTEM
K011219 · JWH
Biomet, Inc.
Orthopedic · 28d
Cleared May 17, 2001
GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM
K010101 · JWH
Kinamed, Inc.
Orthopedic · 126d
Cleared May 17, 2001
EBI DYNAFIX VS OSTEOTOMY SYSTEM
K010551 · NDF
Ebi, L.P.
Orthopedic · 80d
Cleared May 16, 2001
TETHER ACFS
K010466 · KWQ
Theken Surgical,Llc
Orthopedic · 89d
Cleared May 16, 2001
MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWS
K011182 · MNH
Depuyacromed
Orthopedic · 28d
Cleared May 16, 2001
ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1
K011218 · JDI
Exactech, Inc.
Orthopedic · 26d
Cleared May 14, 2001
ARTHREX TWISTLOC SUTURE ANCHOR, MODEL AR-1924
K010457 · MBI
Arthrex, Inc.
Orthopedic · 87d
Cleared May 11, 2001
RT-PLUS MODULAR CEMENTED KNEE COMPONENTS
K003504 · KRO
Plus Orthopedics
Orthopedic · 179d
Cleared May 09, 2001
RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM
K010633 · HWC
Mitek Products
Orthopedic · 68d
Cleared May 08, 2001
MACS MODULAR ANTERIOR CONSTRUCT SYSTEM
K002824 · KWQ
Aesculap, Inc.
Orthopedic · 239d
Cleared May 08, 2001
SURGICAL TITANIUM MESH SYSTEM
K003043 · MQP
Depuyacromed
Orthopedic · 221d
Cleared May 08, 2001
BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR
K003735 · MNI
Blackstone Medical, Inc.
Orthopedic · 155d
Cleared May 08, 2001
CLARIS PLATE SYSTEM
K010369 · MNH
Ortho Tec, LLC
Orthopedic · 90d
Cleared May 08, 2001
MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR
K010479 · HTY
Bonutti Research, Inc.
Orthopedic · 77d
Cleared May 08, 2001
DJ ORTHOPEDICS INTERFERENCE SCREW
K010595 · HWC
Dj Orthopedics, LLC
Orthopedic · 69d
Cleared May 07, 2001
XPS 3000 SYSTEM
K010677 · HRX
Medtronic Xomed, Inc.
Orthopedic · 61d