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
12769–12792 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
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
Cleared Mar 20, 2001
APEX MODULAR ZIRCONIA FEMORAL HEAD
K003923 · LZO
Apex Surgical, LLC
Orthopedic · 90d
Cleared Mar 20, 2001
MODIFICATION TO TRIDENT ALL POLY CUP
K010310 · JDI
Howmedica Osteonics Corp.
Orthopedic · 47d
Cleared Mar 20, 2001
PORTRAIT FEMORAL COMPONENT
K010560 · LZO
Biomet, Inc.
Orthopedic · 22d
Cleared Mar 19, 2001
NEXGEN COMPLETE KNEE SOLUTION CROSS-LINKED POLYETHYLENE CRUCIATE RETAINING...
K003910 · JWH
Zimmer, Inc.
Orthopedic · 90d
Cleared Mar 19, 2001
BAUMER CEMENTED HIP PROSTHESIS
K003975 · JDI
Baumer, S.A
Orthopedic · 87d
Cleared Mar 19, 2001
BAUMER MULLER HIP PROSTHESIS
K003976 · JDI
Baumer, S.A
Orthopedic · 87d
Cleared Mar 19, 2001
SUPER REVO SUTURE ANCHOR
K003984 · MAI
Linvatec Corp.
Orthopedic · 83d
Cleared Mar 19, 2001
TRIFIX SPINAL FIXATION SYSTEM
K010535 · MNH
Endius, Inc.
Orthopedic · 24d
Cleared Mar 13, 2001
MEMOGRAPH
K001354 · JDR
Biomedical Ent., Inc.
Orthopedic · 319d
Cleared Mar 13, 2001
TERRAY STAINLESS STEEL ROD (STRAIGHT, L, RECTANGLE)
K003911 · KWP
Terray Corp.
Orthopedic · 84d
Cleared Mar 13, 2001
OPTETRAK B-SERIES TOTAL KNEE SYSTEM
K010434 · JWH
Exactech, Inc.
Orthopedic · 28d
Cleared Mar 13, 2001
MODIFICATION TO EBI XFIX DFS RAIL SYSTEM
K010437 · KTT
Ebi, L.P.
Orthopedic · 28d