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
11257–11280 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 28, 2004
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K043343 · MNH
Medtronic Sofamor Danek
Orthopedic · 22d
Cleared Dec 28, 2004
CEMEX SYSTEM GENTA FAST BONE CEMENT
K043403 · LOD
Exactech, Inc.
Orthopedic · 18d
Cleared Dec 27, 2004
HERBERT ULNAR HEAD PROSTHESIS SYSTEM
K042902 · KXE
Stuckenbrock Medizintechnik GmbH
Orthopedic · 68d
Cleared Dec 27, 2004
CEMENTEK LV
K042911 · MQV
Teknimed, S.A.
Orthopedic · 67d
Cleared Dec 27, 2004
PARALLAX ACRYLIC RESIN WITH TRACERS, MODEL KP-PAR-003
K042947 · NDN
Arthrocare Corp.
Orthopedic · 62d
Cleared Dec 27, 2004
MODIFICATION TO T2 PROXIMAL HUMERAL NAIL
K043404 · HSB
Howmedica Osteonics Corp.
Orthopedic · 17d
Cleared Dec 22, 2004
DEPUY C-STEM AMT HIP PROSTHESIS
K042959 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 56d
Cleared Dec 21, 2004
TRABECULAR METAL KNEE SYSTEM AUGMENTS
K040487 · MBH
Implex Corp.
Orthopedic · 300d
Cleared Dec 21, 2004
MEDALLION MODULAR HIP SYSTEM
K041850 · LPH
Biomet Manufacturing, Inc.
Orthopedic · 166d
Cleared Dec 21, 2004
APEX K2 HIP SYSTEM
K041950 · LPH
Apex Surgical, LLC
Orthopedic · 154d
Cleared Dec 21, 2004
VERTEX RECONSTRUCTION SYSTEM
K042789 · KWP
Medtronic Sofamor Danek
Orthopedic · 76d
Cleared Dec 21, 2004
M2A/C2A ACETABULAR SYSTEM
K042841 · JDL
Biomet, Inc.
Orthopedic · 68d
Cleared Dec 21, 2004
TRABECULAR METAL ACETABULAR AUGMENTS, MODELS 4894-XXX-YY, 02-212-105XX3,...
K042871 · LPH
Zimmer Trabecular
Orthopedic · 64d
Cleared Dec 21, 2004
MODIFICATION TO ALTIUS OCT SYSTEM
K043229 · KWP
Interpore Cross Intl.
Orthopedic · 29d
Cleared Dec 21, 2004
UCR SPINAL SYSTEM
K043232 · NKB
Seaspine
Orthopedic · 29d
Cleared Dec 20, 2004
OSS/(SCARF)- AND OSW-SCREW
K042079 · HWC
O.M.T. Oberflachen-Und...
Orthopedic · 140d
Cleared Dec 17, 2004
POLYGRAFT BGS
K040047 · MQV
Osteobiologics, Inc.
Orthopedic · 340d
Cleared Dec 17, 2004
TRANS1 AXIAL FIXATION SYSTEM
K040426 · KWQ
Trans1, Inc.
Orthopedic · 302d
Cleared Dec 17, 2004
CONSERVE PLUS HA ACETABULAR SHELLS
K042530 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 91d
Cleared Dec 17, 2004
MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM
K043077 · KWS
Tornier
Orthopedic · 39d
Cleared Dec 17, 2004
MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM
K043181 · KWQ
Vertebron, Inc.
Orthopedic · 30d
Cleared Dec 17, 2004
SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS,...
K043355 · KWP
Sintea Biotech, Inc.
Orthopedic · 11d
Cleared Dec 14, 2004
PLLA CANNULATED INTERFERENCE SCREW
K032830 · HWC
Advanced Biomaterials
Orthopedic · 460d
Cleared Dec 14, 2004
BIO-CORE INTERFERENCE SCREW
K042552 · HWC
Biomet, Inc.
Orthopedic · 85d