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
12769–12792 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
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
Cleared Jun 12, 2001
TROCHANTERIC NAIL
K010780 · HSB
DePuy Orthopaedics, Inc.
Orthopedic · 89d
Cleared Jun 12, 2001
ISOLA BAND CLAMP
K010972 · MNI
Depuyacromed
Orthopedic · 71d
Cleared Jun 12, 2001
TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55
K011007 · MBI
Arthrex, Inc.
Orthopedic · 69d
Cleared Jun 12, 2001
CD HORIZON SPINAL SYSTEM
K011508 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared Jun 12, 2001
T2 HUMERAL NAIL SYSTEM
K011529 · HSB
Howmedica Osteonics Corp.
Orthopedic · 26d
Cleared Jun 06, 2001
USS-LINE EXTENSION
K010108 · MNI
Synthes
Orthopedic · 145d
Cleared Jun 06, 2001
TBW
K010545 · NDL
Tri-Med, Inc.
Orthopedic · 103d
Cleared Jun 06, 2001
TRI-FIX SPINAL FIXATION SYSTEM
K010903 · MNI
Endius, Inc.
Orthopedic · 72d
Cleared Jun 06, 2001
TRI-FIX SPINAL FIXATION SYSTEM
K010922 · MNI
Endius, Inc.
Orthopedic · 71d
Cleared Jun 06, 2001
BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM
K011390 · MBI
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 30d
Cleared Jun 06, 2001
SYNERGY 4.0 MM, 4.5 MM VLS SCREWS
K011437 · MNI
Interpore Cross Intl.
Orthopedic · 27d
Cleared Jun 05, 2001
MODIFICATION TO TSRH SPINAL SYSTEM
K011029 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 61d
Cleared Jun 04, 2001
MODIFIED USS FRACTURE SYSTEM
K010658 · MNI
Synthes (Usa)
Orthopedic · 90d
Cleared May 31, 2001
BUTTERFLY PLATE FUNCTION SYSTEM
K010632 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 90d
Cleared May 30, 2001
SCAPHIX, STAPLE, FIXATION, BONE
K003033 · JDR
Avanta Orthopaedics, Inc.
Orthopedic · 244d