FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,766 results
11401–11424 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 01, 2004
LPS
K033959 · JWH
Depuy, Inc.
Orthopedic · 192d
Cleared Jul 01, 2004
SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM
K040096 · KWP
Spinal Concepts, Inc.
Orthopedic · 163d
Cleared Jul 01, 2004
ARTHREX SMALL FRAGMENT PLATES AND SCREWS
K040907 · HRS
Arthrex, Inc.
Orthopedic · 85d
Cleared Jul 01, 2004
RADIAL NAIL SYSTEM
K040938 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 80d
Cleared Jul 01, 2004
OMEGA 2 SYSTEM
K041001 · KTT
Howmedica Osteonics Corp.
Orthopedic · 73d
Cleared Jul 01, 2004
FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES
K041081 · KTT
Hand Innovations, Inc.
Orthopedic · 66d
Cleared Jul 01, 2004
REVISION KNEE SYSTEM
K041106 · JWH
Smith & Nephew, Inc.
Orthopedic · 64d
Cleared Jul 01, 2004
SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION...
K041449 · KWP
Interpore Cross Intl.
Orthopedic · 30d
Cleared Jul 01, 2004
CD HORIZON SPINAL SYSTEM
K041460 · KWQ
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Jul 01, 2004
TITANIUM FEMORAL KNEE COMPONENTS (MAXIM AND AGC)
K041466 · JWH
Biomet Manufacturing Corp
Orthopedic · 29d
Cleared Jul 01, 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K041556 · MQP
Medtronic Sofamor Danek
Orthopedic · 21d
Cleared Jul 01, 2004
MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE...
K041656 · LOD
DePuy Orthopaedics, Inc.
Orthopedic · 13d
Cleared Jun 30, 2004
LACTOSCREW SCREW ANCHOR
K033355 · HWC
Biomet Orthopedics, Inc.
Orthopedic · 254d
Cleared Jun 30, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K041030 · MNI
Medtronic Sofamor Danek
Orthopedic · 70d
Cleared Jun 25, 2004
EBI DISTAL RADIUS PLATING SYSTEM
K040908 · HRS
Ebi, L.P.
Orthopedic · 79d
Cleared Jun 25, 2004
CONSERVE PLUS REVISION SHELL AND CONSERVE PLUS THICK SHELL
K041425 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 28d
Cleared Jun 25, 2004
OPUS MAGNUM ANCHOR WITH INSERTER
K041440 · MBI
Opus Medical, Inc.
Orthopedic · 24d
Cleared Jun 24, 2004
BIO-EUROLIG INTERFERENCE SCREW
K031939 · HWC
Fournitures Hospitalieres Industrie
Orthopedic · 367d
Cleared Jun 24, 2004
WAFER SYSTEM
K033303 · HRS
Spine Wave, Inc.
Orthopedic · 254d
Cleared Jun 24, 2004
TSY SHOULDER PLATE IMPLANT
K040850 · HRS
Orthopedic Sciences, Inc.
Orthopedic · 85d
Cleared Jun 24, 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K041452 · MQP
Medtronic Sofamor Danek
Orthopedic · 23d
Cleared Jun 18, 2004
LCP RADIAL HEAD PLATING SYSTEM
K040777 · HRS
Synthes (Usa)
Orthopedic · 84d
Cleared Jun 17, 2004
SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
K040612 · HRX
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 101d
Cleared Jun 17, 2004
ASSURE ANTERIOR CERVICAL PLATE SYSTEM
K040721 · KWQ
Globus Medical, Inc.
Orthopedic · 90d