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
11425–11448 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 25, 2004
BICONTACT HIP STEM AND FEMORAL HEAD
K040191 · LPH
Aesculap
Orthopedic · 210d
Cleared Aug 25, 2004
MODIFICATION TO RESTORATION MODULAR SYSTEM
K040734 · LZO
Howmedica Osteonics Corp.
Orthopedic · 156d
Cleared Aug 25, 2004
ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30,...
K041451 · KYI
Ascension Orthopedics, Inc.
Orthopedic · 85d
Cleared Aug 25, 2004
SNAP-OFF SCREWS
K041456 · HWC
Fournitures Hospitalieres Industrie
Orthopedic · 85d
Cleared Aug 25, 2004
NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE
K041613 · MQV
Novabone Products, LLC
Orthopedic · 71d
Cleared Aug 25, 2004
BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID
K041616 · MQV
Orthos (Uk) Limited
Orthopedic · 71d
Cleared Aug 25, 2004
AEQUALIS REVERSED SHOULDER PROSTHESIS
K041873 · PHX
Tornier
Orthopedic · 44d
Cleared Aug 25, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K042025 · KWQ
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Aug 25, 2004
KLSA MARTIN HAND DISTRACTOR
K042066 · JEC
KLS-Martin L.P.
Orthopedic · 23d
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