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
11761–11784 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 19, 2003
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ
K033384 · JDK
Implex Corp.
Orthopedic · 27d
Cleared Nov 18, 2003
DELTA SHOULDER
K021478 · PHX
Depuy, Inc.
Orthopedic · 559d
Cleared Nov 18, 2003
ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS
K031666 · HRS
Arthrex, Inc.
Orthopedic · 173d
Cleared Nov 14, 2003
CLICK'X MONOAXIAL SCREWS AND HOOKS
K031175 · KWP
Synthes (Usa)
Orthopedic · 214d
Cleared Nov 14, 2003
PASSMED SPINAL SYSTEM
K032094 · KWP
Medicrea
Orthopedic · 130d
Cleared Nov 14, 2003
DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS
K033329 · HSB
Depuy, Inc.
Orthopedic · 29d
Cleared Nov 13, 2003
NUVASIVE MESH
K032476 · MQP
Nuvasive, Inc.
Orthopedic · 93d
Cleared Nov 13, 2003
STELKAST UNICONDYLAR KNEE SYSTEM
K032824 · HSX
Stelkast Company
Orthopedic · 64d
Cleared Nov 13, 2003
EXACTECH 12/14 ALUMINA FEMORAL HEAD
K032964 · LPH
Exactech, Inc.
Orthopedic · 51d
Cleared Nov 13, 2003
MODIFICATION TO STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM
K033252 · HWC
Stryker Endoscopy
Orthopedic · 36d
Cleared Nov 07, 2003
DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBE
K032473 · HRX
Stryker Instruments
Orthopedic · 87d
Cleared Nov 06, 2003
DYNALOK CLASSIC SPINAL SYSTEM
K033271 · MNI
Medtronic Sofamor Danek
Orthopedic · 27d
Cleared Nov 05, 2003
VITOSS-FILLED CARTRIDGE
K032130 · MQV
Orthovita, Inc.
Orthopedic · 117d
Cleared Nov 05, 2003
VERSYS BEADED FULLCOAT CALCAR HIP PROSTHESIS
K033034 · LPH
Zimmer, Inc.
Orthopedic · 37d
Cleared Nov 05, 2003
SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM
K033071 · JDS
Synthes (Usa)
Orthopedic · 37d
Cleared Nov 05, 2003
WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347,...
K033112 · KTT
Hand Biomechanics Lab, Inc.
Orthopedic · 36d
Cleared Nov 05, 2003
HOFFMANN II PELVIC CLAMP
K033145 · LXT
Howmedica Osteonics Corp.
Orthopedic · 36d
Cleared Nov 05, 2003
SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES
K033158 · KTT
Synthes (Usa)
Orthopedic · 36d
Cleared Nov 05, 2003
LACTOSORB TIBIAL L-15 SCREW AND WASHER
K033233 · HWC
Biomet, Inc.
Orthopedic · 30d
Cleared Oct 31, 2003
CONSERVE PLUS SPIKED ACETABULAR SHELLS AND CONSERVE TOTAL 56MM FEMORAL HEAD
K031963 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 128d
Cleared Oct 31, 2003
PLUS PIVOT LINK UNIVERSAL SYSTEM
K032398 · MNI
Spine Vision, Inc.
Orthopedic · 88d
Cleared Oct 31, 2003
HEDROCEL VERTEBRAL BODY REPLACEMENT
K032527 · MQP
Implex Corp.
Orthopedic · 77d
Cleared Oct 30, 2003
POWER CONTROL 2303 WITH POWER STICK M4, MODEL# 2303.011/.901/.911, 8564.121/.851
K030082 · HRX
Richard Wolf Medical Instruments Corp.
Orthopedic · 294d
Cleared Oct 30, 2003
PROFUSION BONE VOID FILLER KIT
K031838 · MQV
Biogeneration
Orthopedic · 136d