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
11569–11592 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 19, 2004
SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW
K040542 · HWC
Smith & Nephew, Inc.
Orthopedic · 170d
Cleared Aug 19, 2004
CEMENTEK
K041493 · MQV
Teknimed, S.A.
Orthopedic · 76d
Cleared Aug 19, 2004
TRI-OSTETIC
K041889 · MQV
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 38d
Cleared Aug 17, 2004
EXPEDIUM ANTERIOR SPINE SYSTEM
K041205 · KWQ
Depuy Spine, Inc.
Orthopedic · 102d
Cleared Aug 17, 2004
FASSIER-DUVAL TELSCOPIC IM SYSTEM
K041393 · HSB
Pega Medical, Inc.
Orthopedic · 85d
Cleared Aug 17, 2004
BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM LORDOTIC LATERAL SPACERS
K041939 · MQP
Blackstone Medical, Inc.
Orthopedic · 29d
Cleared Aug 16, 2004
INION TRINION BIODEGRADABLE MENISCUS SCREW
K031714 · HWC
Inion , Ltd.
Orthopedic · 441d
Cleared Aug 16, 2004
POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX,...
K033707 · MQV
Osteobiologics, Inc.
Orthopedic · 264d
Cleared Aug 16, 2004
EBI LACTOSORB GRAFT CONTAINMENT SYSTEM
K033918 · HRS
Ebi, L.P.
Orthopedic · 242d
Cleared Aug 16, 2004
NUVASIVE ANTERIOR CERVICAL PLATE SYSTEM
K041447 · KWQ
Nuvasive, Inc.
Orthopedic · 76d
Cleared Aug 16, 2004
KMI DISTAL VOLAR RADIUS PLATE SYSTEM
K041461 · HRS
Kinetikos Medical, Inc.
Orthopedic · 75d
Cleared Aug 10, 2004
CURVED PEEK TETRIS SPINAL IMPLANT
K041888 · MQP
Signus Medizintechnik GmbH
Orthopedic · 29d
Cleared Aug 09, 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K041197 · MQP
Medtronic Sofamor Danek
Orthopedic · 94d
Cleared Aug 05, 2004
NEXFLEX TOTAL HIP SYSTEM
K033580 · LPH
Nexmed, Inc.
Orthopedic · 266d
Cleared Aug 05, 2004
STRYKER SPINE VERTEBRAL SPACER
K040731 · MQP
Stryker Spine
Orthopedic · 136d
Cleared Aug 05, 2004
VILEX BONE PLATE SYSTEM
K041287 · HWC
Vilex, Inc.
Orthopedic · 84d
Cleared Aug 05, 2004
TALUS OF VILEX (TOV)
K041289 · HWC
Vilex, Inc.
Orthopedic · 84d
Cleared Aug 04, 2004
PORE-SI BONE GRAFT SUBSTITUTE
K040082 · MQV
Apatech , Ltd.
Orthopedic · 202d
Cleared Aug 02, 2004
ALLOMATRIX PUTTY
K041168 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Jul 30, 2004
MODIFICATION TO SMALL BONE FIXATION SYSTEM
K041157 · HTY
Hand Innovations, Inc.
Orthopedic · 88d
Cleared Jul 30, 2004
COMPRESS DISTAL FEMORAL REPLACEMENT SYSTEM
K041352 · KRO
Biomet, Inc.
Orthopedic · 71d
Cleared Jul 30, 2004
HUMERAL STAPLE
K041355 · HTY
Smith & Nephew, Inc.
Orthopedic · 71d
Cleared Jul 30, 2004
ANTERIOR COMPACT SYSTEM
K041469 · KWQ
X-Spine Systems
Orthopedic · 58d
Cleared Jul 29, 2004
SUTURE ARROW
K041128 · MAI
Linvatec Corp.
Orthopedic · 90d