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
12313–12336 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 22, 2002
XANTUS ANTERIOR LATERAL SUPPLEMENTAL FIXATION SYSTEM
K022070 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 26d
Cleared Jul 18, 2002
MICOMED POSTERIOR DOUBLEROD SYSTEM
K021275 · MNI
Micomed Ortho GmbH
Orthopedic · 87d
Cleared Jul 18, 2002
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K022015 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Jul 17, 2002
HLS NOETOS SYSTEM
K013906 · JWH
Tornier
Orthopedic · 233d
Cleared Jul 17, 2002
LACTOSORB MINI INTERFERENCE SCREW
K021254 · HWC
Biomet Orthopedics, Inc.
Orthopedic · 89d
Cleared Jul 17, 2002
INION HEXALON BIODEGRADABLE ACL/PCL SCREW
K021280 · HWC
Inion , Ltd.
Orthopedic · 86d
Cleared Jul 17, 2002
WRIST FUSION PLATE
K021321 · HRS
Acu Med, Inc.
Orthopedic · 83d
Cleared Jul 17, 2002
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODELS 06-112-00XX2 AND 06-132-10XX2
K021967 · MQP
Implex Corp.
Orthopedic · 30d
Cleared Jul 12, 2002
3D KNEE
K020114 · JWH
Encore Orthopedics, Inc.
Orthopedic · 182d
Cleared Jul 12, 2002
THE TRABECULAR METAL MONOBLOCK CUP, MODELS 00-7259-0XX-28 (ZIMMER CAT. #) AND...
K021970 · LPH
Implex Corp.
Orthopedic · 25d
Cleared Jul 11, 2002
AMC ANTIMICROBIAL PIN/WIRE SLEEVE
K012193 · JEC
Smith & Nephew, Inc.
Orthopedic · 364d
Cleared Jul 11, 2002
MONARCH SPINE SYSTEM
K021335 · MNH
Depuyacromed
Orthopedic · 76d
Cleared Jul 09, 2002
TSRH SPINAL SYSTEM
K021170 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 88d
Cleared Jul 09, 2002
PROVEN MODULAR POSTERIOR STABILIZED FEMORAL
K021908 · JWH
Stelkast Company
Orthopedic · 29d
Cleared Jul 03, 2002
SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05,...
K021919 · KWP
Ortho Tec, LLC
Orthopedic · 22d
Cleared Jul 02, 2002
STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX
K021346 · LPH
Wrightmedicaltechnologyinc
Orthopedic · 64d
Cleared Jul 02, 2002
TRIDENT CROSSFIRE POLYUETHYLENE LINERS
K021911 · LPH
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Jul 01, 2002
VERTEBRAL SPACER
K011037 · MQP
Synthes (Usa)
Orthopedic · 452d
Cleared Jul 01, 2002
GREAT TOE IMPLANT
K021063 · KWD
Signal Medical Corp.
Orthopedic · 90d
Cleared Jul 01, 2002
MACROPORE OS TRAUMA
K021164 · HRS
Macropore Biosurgery, Inc.
Orthopedic · 81d
Cleared Jul 01, 2002
METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES)
K021349 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 63d
Cleared Jul 01, 2002
MODIFICATION TO SPIRAL RADIUS 90-D SST SYSTEM
K021825 · KWP
Unitedstates Surgical
Orthopedic · 27d
Cleared Jul 01, 2002
SMALL HAMMER TOE PIN
K021828 · HWC
Biomet, Inc.
Orthopedic · 27d
Cleared Jul 01, 2002
BIOFASTIN RC THREADED SUTURE ANCHOR
K021883 · HWC
Mitek Worldwide
Orthopedic · 24d