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
12889–12912 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 27, 2001
SYNTHES STERNAL FIXATION SYSTEM
K010943 · JDQ
Synthes (Usa)
Orthopedic · 90d
Cleared Jun 27, 2001
SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM
K011034 · KTT
Synthes (Usa)
Orthopedic · 83d
Cleared Jun 27, 2001
SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER ANCHOR
K011299 · MAI
Smith & Nephew, Inc.
Orthopedic · 58d
Cleared Jun 27, 2001
EBI XFIX ACCESS PELVIC FIXATOR
K011697 · KTT
Ebi, L.P.
Orthopedic · 26d
Cleared Jun 20, 2001
TITANIUM COMPRESSION ANCHOR SYSTEM
K010884 · HWC
Anchor Medical Technologies
Orthopedic · 89d
Cleared Jun 19, 2001
PFC SIGMA LUGGED TIBIAL TRAY
K003026 · JWH
DePuy Orthopaedics, Inc.
Orthopedic · 264d
Cleared Jun 19, 2001
K'FIX
K010847 · NDL
Avanta Orthopaedics, Inc.
Orthopedic · 90d
Cleared Jun 19, 2001
FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL B
K010901 · HSB
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 85d
Cleared Jun 19, 2001
KSEA MINIATURE TELESCOPE AND ACCESSORIES
K010987 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 78d
Cleared Jun 19, 2001
FIXION INTERLOCKING PROXIMAL FEMORAL NAILING SYSTEM
K010988 · HSB
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 78d
Cleared Jun 19, 2001
RESORBABLE HAMMERTOE PIN
K011137 · JDW
Biomet, Inc.
Orthopedic · 67d
Cleared Jun 19, 2001
ARTHREX BIO-TRANSFIX
K011172 · MNU
Arthrex, Inc.
Orthopedic · 63d
Cleared Jun 19, 2001
TORNIER TOTAL ELBOW PROSTHESIS
K011567 · JDB
Tornier
Orthopedic · 29d
Cleared Jun 19, 2001
RADIAL HEAD IMPLANT
K011819 · KWI
Avanta Orthopaedics, Inc.
Orthopedic · 8d
Cleared Jun 15, 2001
MODIFICATION TO THE BOLD SCREW
K011262 · HWC
New Deal, S.A.
Orthopedic · 51d
Cleared Jun 15, 2001
EXCEL FRACTURE CEMENTED HIP STEM
K011367 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 42d
Cleared Jun 15, 2001
OSTEO IC FEMORAL AND TIBIAL NAILS AND OSTEO RETROGRADE/ANTEGRADE FEMORAL...
K011622 · HSB
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Jun 15, 2001
EXETER HIP SYSTEM WITH V40 TAPER
K011623 · JDI
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Jun 13, 2001
MEMODYN STAPLE
K002695 · JDR
Telos Medical Equipment
Orthopedic · 288d
Cleared Jun 13, 2001
PLLA PIN
K010983 · HTY
Bionx Implants, Inc.
Orthopedic · 72d
Cleared Jun 13, 2001
BARRETT UNICONDYLAR TIBIAL BEARING
K011509 · HRY
Biomet, Inc.
Orthopedic · 28d
Cleared Jun 13, 2001
WORLAND UNICONDYLAR TIBIAL BEARING
K011795 · HRY
Biomet, Inc.
Orthopedic · 5d
Cleared Jun 12, 2001
CD HORIZON SPINAL SYSTEM, 4.5 ROD FOR POSTERIOR APPLICATION
K010181 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 144d
Cleared Jun 12, 2001
SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE
K010766 · KTT
Synthes (Usa)
Orthopedic · 90d