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
9409–9432 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 26, 2009
COALITION SPACER
K083389 · OVE
Globus Medical, Inc.
Orthopedic · 129d
Cleared Mar 26, 2009
AOS PROXIMAL HUMERAL NAIL
K090478 · HSB
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 30d
Cleared Mar 25, 2009
STRYKER SPINE NULOCK ANTERIOR CERVICAL PLATING SYSTEM
K083562 · KWQ
Stryker Corp.
Orthopedic · 113d
Cleared Mar 25, 2009
DISCOVERY ELBOW - X-SMALL
K090473 · JDC
Biomet Manufacturing Corp
Orthopedic · 29d
Cleared Mar 24, 2009
EQUIVABONE
K090310 · MQV
Etex Corp.
Orthopedic · 46d
Cleared Mar 23, 2009
ACE FISCHER EXTERNAL FIXATION SYSTEM
K083789 · KTT
DePuy Orthopaedics, Inc.
Orthopedic · 94d
Cleared Mar 20, 2009
NUVASIVE HELIX-T ACP SYSTEM
K083341 · KWQ
Nuvasive, Inc.
Orthopedic · 128d
Cleared Mar 20, 2009
FUSION ADVANTAGE CERVICAL CAGE, FUSION ADVANTAGE LUMBAR CAGE
K083425 · ODP
Adaptive Specialty, LLC
Orthopedic · 121d
Cleared Mar 20, 2009
OSCAR BONE RESECTOR
K083830 · JDX
Orthosonics, Ltd.
Orthopedic · 87d
Cleared Mar 20, 2009
LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM
K083843 · HRS
DePuy Orthopaedics, Inc.
Orthopedic · 86d
Cleared Mar 20, 2009
MODIFICATION TO: DSS STABILIZATION SYSTEM
K090408 · NKB
Paradigm Spine, LLC
Orthopedic · 30d
Cleared Mar 19, 2009
EOI SPINAL SYSTEM
K083825 · NKB
Expanding Orthopedics, Inc.
Orthopedic · 87d
Cleared Mar 18, 2009
BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685
K083490 · HTY
Biopro, Inc.
Orthopedic · 113d
Cleared Mar 17, 2009
SALTO TALARIS TOTAL ANKLE PROSTHESIS
K090076 · HSN
Tornier
Orthopedic · 64d
Cleared Mar 13, 2009
THEKEN ATOLL CERVICO-THORACIC SYSTEM
K083073 · MNI
Theken Spine, LLC
Orthopedic · 149d
Cleared Mar 13, 2009
REVELATION STEM, MODEL 427-21/42-080/180
K083651 · KWA
Encore Medical, L.P.
Orthopedic · 94d
Cleared Mar 13, 2009
MAGNUM M FIXATION DEVICE
K090380 · MBI
Arthrocare Corp.
Orthopedic · 24d
Cleared Mar 12, 2009
UNIVERSAL COMPRESSION FRACTURE REPAIR SYSTEM
K081813 · HWC
U.S. Implant Solutions, LLC
Orthopedic · 259d
Cleared Mar 11, 2009
PEDINAIL INTRAMEDULLARY NAILING SYSTEM
K083726 · HSB
OrthoPediatrics Corp.
Orthopedic · 86d
Cleared Mar 11, 2009
BIOLOX DELTA CERAMIC FEMORAL HEADS
K083762 · LZO
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared Mar 11, 2009
GRYPHON P BR DS ANCHOR W/ORTHOCORD,GRYPHON P BR ANCHOR W/ORTHOCORD, MODEL...
K090124 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 49d
Cleared Mar 11, 2009
PIGALILEO TKR BASE V2.3 AND CAS V4.1
K090313 · OLO
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Mar 11, 2009
STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2,...
K090374 · LXT
DePuy Orthopaedics, Inc.
Orthopedic · 22d
Cleared Mar 06, 2009
DYNASTY POROUS ACETABULAR SHELL, DYNASTY POLYETHYLENE ACETABULAR LINER,...
K082924 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 156d