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
12745–12768 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 05, 2001
AUTO-DRIVE LAG SCREW SYSTEM
K010964 · HWC
Osteomed Corp.
Orthopedic · 97d
Cleared Jul 05, 2001
SYNTHES 2.7 MM LC-DCP, 3.5 MM PROFILE
K011170 · HRS
Synthes (Usa)
Orthopedic · 79d
Cleared Jul 02, 2001
M2A ACETABULAR SYSTEM
K011110 · KWA
Biomet, Inc.
Orthopedic · 82d
Cleared Jul 02, 2001
PLUS CANCELLOUS BONE SCREWS
K011719 · HWC
Plus Orthopedics
Orthopedic · 28d
Cleared Jun 29, 2001
MODIFICATION TO EBI EFIX VISION FIXATION SYSTEM
K011711 · KTT
Ebi, L.P.
Orthopedic · 25d
Cleared Jun 28, 2001
GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT
K011047 · MBF
DePuy Orthopaedics, Inc.
Orthopedic · 83d
Cleared Jun 28, 2001
ARTHROCARE SYSTEM 2000 CONTROLLER, CABLE, FOOTSWITCH, POWER CORD & ARTHROCARE...
K011083 · HRX
Arthrocare Corp.
Orthopedic · 79d
Cleared Jun 28, 2001
SCORPIO CR SUPERFLEX TIBIAL INSERT
K011643 · JWH
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Jun 27, 2001
ORTHOGENESIS LPS SYSTEM
K003182 · JWH
Depuy, Inc.
Orthopedic · 259d
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