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
12841–12864 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Apr 17, 2001
WUJIN #3 FEMORAL NAIL
K010149 · HSB
Biopro, Inc.
Orthopedic · 90d
Cleared Apr 16, 2001
REFLEX ANTERIOR CERVICAL PLATE SYSTEM
K010115 · KWQ
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Apr 13, 2001
AVL HINGE KNEE SYSTEM
K010774 · KRO
Biomet, Inc.
Orthopedic · 30d
Cleared Apr 12, 2001
MOSS MIAMI 5.5MM TITANIUM PIN NUT
K010742 · MNH
Depuyacromed
Orthopedic · 30d
Cleared Apr 11, 2001
SOCON SPINAL SYSTEM
K003463 · MNH
Aesculap, Inc.
Orthopedic · 155d
Cleared Apr 11, 2001
TSRH SPINAL SYSTEM
K010720 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 30d
Cleared Apr 11, 2001
LFIT V40 FEMORAL HEAD COMPONENTS
K010757 · JDI
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Apr 11, 2001
ULNAR HEAD IMPLANT
K010786 · KXE
Avanta Orthopaedics, Inc.
Orthopedic · 27d
Cleared Apr 09, 2001
MODIFICATION TO SYNTHES (USA) POLYPIN
K003527 · HTY
Synthes (Usa)
Orthopedic · 144d
Cleared Apr 06, 2001
LPC-PLUS ACETABULAR CUP
K003274 · LZO
Plus Orthopedics
Orthopedic · 170d
Cleared Apr 06, 2001
AVON PATELLO-FEMORAL JOINT PROSTHESIS
K010100 · KRR
Howmedica Osteonics Corp.
Orthopedic · 85d
Cleared Apr 06, 2001
ARTHREX UNIVERS 30 SHOULDER PROSTHESIS
K010124 · KWS
Arthrex, Inc.
Orthopedic · 80d
Cleared Apr 06, 2001
DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER
K010171 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 78d
Cleared Apr 06, 2001
TRINITY POLYAXIAL SCREW, MEHDIAN SPINAL ROD (6MM), MODEL 159.XXX SERIES...
K010776 · MNH
Corin USA
Orthopedic · 23d
Cleared Apr 06, 2001
T2 FEMORAL NAIL
K010801 · HSB
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Apr 05, 2001
COPELAND RESURFACING HUMERAL HEADS
K010664 · HSD
Biomet Manufacturing, Inc.
Orthopedic · 30d
Cleared Apr 02, 2001
MODIFICATION TO MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM (8 MM...
K010685 · HSX
Zimmer, Inc.
Orthopedic · 25d
Cleared Mar 26, 2001
DJ ORTHOPEDICS FEMORAL ANCHOR
K002829 · MBI
Dj Orthopedics, LLC
Orthopedic · 196d
Cleared Mar 22, 2001
MODIFICATION TO SYNERGY SPINAL SYSTEM
K010515 · KWP
Interpore Cross Intl.
Orthopedic · 28d
Cleared Mar 21, 2001
PECTOFIX STERNAL REPAIR WIRE
K003951 · JDQ
Pectofix, Inc.
Orthopedic · 90d
Cleared Mar 21, 2001
DJ ORTHOPEDICS TIBIAL ANCHOR
K003960 · MBI
Dj Orthopedics, LLC
Orthopedic · 90d
Cleared Mar 21, 2001
AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR
K003971 · MBI
Axya Medical, Inc.
Orthopedic · 89d
Cleared Mar 20, 2001
ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION
K001535 · KWP
Ortho Tec, LLC
Orthopedic · 307d
Cleared Mar 20, 2001
LACTOSORB 5.0 MM WASHER
K001581 · HWC
Biomet, Inc.
Orthopedic · 302d