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
11641–11664 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 05, 2004
NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM
K033810 · HRY
Centerpulse Orthopedics, Inc.
Orthopedic · 88d
Cleared Mar 05, 2004
CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY
K040405 · MQV
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 17d
Cleared Mar 04, 2004
SYNTHES VENTROFIX MIS SYSTEM
K031100 · KWQ
Synthes (Usa)
Orthopedic · 332d
Cleared Mar 04, 2004
SHIRAZ POSTERIOR SYSTEM
K033947 · MNI
Spine Next America
Orthopedic · 76d
Cleared Mar 04, 2004
SHIRAZ-ANTERIOR SYSTEM
K033965 · KWQ
Spine Next America
Orthopedic · 73d
Cleared Mar 03, 2004
BLACKSTONE ASCENT POCT SYSTEM HOOKS (SYSTEM MODIFICATION)
K033980 · KWP
Blackstone Medical, Inc.
Orthopedic · 71d
Cleared Mar 02, 2004
SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM
K033816 · JDQ
Synthes (Usa)
Orthopedic · 84d
Cleared Mar 01, 2004
CANNULATED METALLIC HEMI TOE IMPLANT, MODELS MPJ241975, MPJ221775, MPJ211675,...
K023684 · KWD
Vilex, Inc.
Orthopedic · 486d
Cleared Mar 01, 2004
INION OTPS BIODEGRADABLE MESH PLATING SYSTEM
K031961 · HRS
Inion , Ltd.
Orthopedic · 250d
Cleared Mar 01, 2004
ART POSTERIOR SPINAL SYSTEM
K033150 · MNI
Advanced Medical Technologies AG
Orthopedic · 153d
Cleared Mar 01, 2004
BILOK ST SCREW
K033792 · HWC
Biocomposites, Ltd.
Orthopedic · 87d
Cleared Mar 01, 2004
SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS
K033975 · HWC
Synthes (Usa)
Orthopedic · 69d
Cleared Mar 01, 2004
3.5 MM LCP DISTAL HUMERUS SYSTEM
K033995 · KTT
Synthes (Usa)
Orthopedic · 68d
Cleared Mar 01, 2004
KOMPRESSOR SCREW SYSTEM
K040356 · HWC
Kinetikos Medical, Inc.
Orthopedic · 17d
Cleared Feb 27, 2004
EXACTECH RESORBABLE BONE PASTE
K020078 · MQV
Exactech, Inc.
Orthopedic · 779d
Cleared Feb 25, 2004
VERTEBRON PSS PEDICLE SCREW SYSTEM
K033352 · MNI
Vertebron, Inc.
Orthopedic · 128d
Cleared Feb 25, 2004
TRANSET FRACTURE FIXATION SYSTEM
K033717 · HTY
Bonutti Research, Inc.
Orthopedic · 91d
Cleared Feb 23, 2004
TITANIUM CANNULATED INTERFERENCE SCREW
K033749 · HWC
Advanced Biomaterials
Orthopedic · 84d
Cleared Feb 23, 2004
DEPUY SIGMA XLK TIBIAL INSERTS
K040166 · JWH
DePuy Orthopaedics, Inc.
Orthopedic · 28d
Cleared Feb 20, 2004
THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEM
K032064 · MQP
Theken Surgical,Llc
Orthopedic · 232d
Cleared Feb 20, 2004
STRYKER SPINE OASYS SYSTEM
K032394 · MNI
Howmedica Osteonics Corp.
Orthopedic · 200d
Cleared Feb 20, 2004
SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES
K033805 · LXT
Synthes (Usa)
Orthopedic · 74d
Cleared Feb 20, 2004
ACE PROXIMAL HUMERAL NAIL SYSTEM
K033806 · HSB
Depuy Ace
Orthopedic · 74d
Cleared Feb 20, 2004
ACE ANTEGRADE RETROGRADE HUMERAL NAIL SYSTEM
K033878 · HSB
Depuy Ace
Orthopedic · 67d