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
13537–13560 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 16, 1998
SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM
K983530 · KWP
Synthes (Usa)
Orthopedic · 69d
Cleared Dec 16, 1998
DYNA-LOK SPINAL SYSTEM
K983672 · MNI
Sofamor Danek USA,Inc.
Orthopedic · 58d
Cleared Dec 16, 1998
PEDIATRIC CANNULATED OSTEOTOMY PLATES
K983967 · HRS
Biomet, Inc.
Orthopedic · 40d
Cleared Dec 16, 1998
OSTEO 9MM IC TIBIAL NAIL
K984353 · HSB
Osteonics Corp.
Orthopedic · 9d
Cleared Dec 11, 1998
DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION
K980626 · JDI
Howmedica Corp.
Orthopedic · 296d
Cleared Dec 11, 1998
DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION
K980632 · JWH
Howmedica Corp.
Orthopedic · 295d
Cleared Dec 11, 1998
OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM
K983382 · MEH
Osteonics Corp.
Orthopedic · 77d
Cleared Dec 07, 1998
KSEA C-MOUNT ARTHROSCOPES
K983142 · HRX
Karl Storz Endoscopy
Orthopedic · 90d
Cleared Dec 07, 1998
OSTEO COMPRESSION CONDYLE SCREW SYSTEM
K983508 · HWC
Osteonics Corp.
Orthopedic · 61d
Cleared Dec 04, 1998
ULNAR HEAD IMPLANT
K982268 · KXE
Avanta Orthopaedics, Inc.
Orthopedic · 158d
Cleared Dec 04, 1998
G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER)
K982812 · KWY
Johnson & Johnson Professionals, Inc.
Orthopedic · 115d
Cleared Dec 04, 1998
NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTS
K983153 · JWH
Sulzer Orthopedics, Inc.
Orthopedic · 86d
Cleared Dec 04, 1998
OSTEONICS X CEMENTED HIP STEM SERIES
K983226 · JDI
Osteonics Corp.
Orthopedic · 80d
Cleared Dec 04, 1998
HOLLAND FEMORAL NAIL SYSTEM
K983641 · HSB
Biomet, Inc.
Orthopedic · 49d
Cleared Dec 04, 1998
BONE BAND
K983685 · LYT
Chapel and Assoc.
Orthopedic · 45d
Cleared Dec 04, 1998
SYNTEC-TAICHUNG NON-STERILE KNOWLES PIN, MODELS: FOR HEXAGONAL COLLAR:...
K983757 · JDW
Syntec Scientific Corp.
Orthopedic · 42d
Cleared Dec 04, 1998
COBRA EXTERNAL FIXATOR
K983881 · HRS
Orthopaedic Innovations, Inc.
Orthopedic · 32d
Cleared Dec 04, 1998
INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAP
K983942 · JDS
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Dec 03, 1998
IMPLEX HEDROCEL REPLACEMENT CUP INSERT MODEL NUMBERS 02-246-XXYYY,...
K983128 · JDI
Implex Corp.
Orthopedic · 86d
Cleared Dec 03, 1998
OSTEO 4.0MM CANNULATED SCREW SYSTEM
K983165 · HWC
Osteonics Corp.
Orthopedic · 84d
Cleared Dec 03, 1998
NELSON RESURFACING HEAD
K983452 · KXA
Biomet, Inc.
Orthopedic · 64d
Cleared Dec 03, 1998
DEPUY ACROMED MOSS AND MOSS MIAMI SPINAL SYSTEMS
K983583 · KWP
Depuy, Inc.
Orthopedic · 51d
Cleared Dec 02, 1998
DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINER
K983491 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 58d
Cleared Dec 02, 1998
150MM COCR BIMETRIC HEAD/NECK REPLACEMENT HIP STEM- COLOR BUFF FINISH
K983710 · JDI
Biomet, Inc.
Orthopedic · 42d