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
13489–13512 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 01, 1999
OSTEONICS COMBINATION SCREW RING/BLOCKER
K990158 · MNI
Osteonics Corp.
Orthopedic · 13d
Cleared Jan 28, 1999
CD HORIZON SPINAL SYSTEM
K981676 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 261d
Cleared Jan 28, 1999
INNOVASIVE DEVICES INTRATUNNEL TIBIAL FIXATION FASTENER
K983560 · MBI
Innovasive Devices, Inc.
Orthopedic · 107d
Cleared Jan 28, 1999
SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWS
K983592 · HWC
Sulzer Orthopedics, Inc.
Orthopedic · 107d
Cleared Jan 28, 1999
P.F.C. MODULAR PLUS OFFSET TIBIAL TRAY
K984158 · JWH
Depuy, Inc.
Orthopedic · 70d
Cleared Jan 28, 1999
BIOABSORBABLE INTERFERENCE SCREWS
K984320 · HWC
Smith & Nephew, Inc.
Orthopedic · 56d
Cleared Jan 28, 1999
DEPUY PROFILE FEMORAL HIP WITH POROCOAT
K984459 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 44d
Cleared Jan 28, 1999
OSTEONICS SPINAL SYSTEM-EXPANDED INDICATIONS
K990059 · MNI
Howmedica Osteonics Corp.
Orthopedic · 20d
Cleared Jan 27, 1999
LACTOSORB MENISCAL REPAIR DEVICE
K982095 · MAI
Biomet, Inc.
Orthopedic · 226d
Cleared Jan 27, 1999
SYNTEC-TAICHUNG NON-STERILE TITANIUM ALLOY MINI-PLATE
K983988 · HRS
Syntec Scientific Corp.
Orthopedic · 79d
Cleared Jan 21, 1999
SYNTHES PROXIMAL TIBIA PLATING SYSTEM
K983787 · HRS
Synthes (Usa)
Orthopedic · 86d
Cleared Jan 21, 1999
STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM
K984200 · MBI
R. Thomas Grotz, M.D., Inc.
Orthopedic · 58d
Cleared Jan 21, 1999
SYNTHES SPINE CERVIFIX SYSTEM
K984377 · KWP
Synthes (Usa)
Orthopedic · 49d
Cleared Jan 20, 1999
MICOMED - HALM ZIELKE INSTRUMENTATION
K982006 · KWQ
Micomed GmbH
Orthopedic · 226d
Cleared Jan 20, 1999
ODI ULTIMATE COMPRESSION HIP SCREW
K984331 · HWC
Orthopedic Designs, Inc.
Orthopedic · 48d
Cleared Jan 20, 1999
TIMX LOW BACK SYSTEM
K984348 · MNI
Depuy Motech Acromed
Orthopedic · 47d
Cleared Jan 20, 1999
VSP SYSTEM
K984350 · MNI
Depuy Motech Acromed
Orthopedic · 47d
Cleared Jan 19, 1999
MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM
K982875 · KWQ
Danek Medical, Inc.
Orthopedic · 158d
Cleared Jan 19, 1999
EBI SPINELINK SYSTEM
K984027 · MNI
Electro-Biology, Inc.
Orthopedic · 68d
Cleared Jan 19, 1999
THE NEW BIO-MOORE ENDO HEADS
K984028 · KWL
Biomet, Inc.
Orthopedic · 68d
Cleared Jan 19, 1999
SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM
K984612 · MNI
Synthes Spine
Orthopedic · 26d
Cleared Jan 14, 1999
GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM
K983814 · JDO
Efratgo, Ltd. HI Tech Bio-Surgical
Orthopedic · 78d
Cleared Jan 14, 1999
GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD
K984541 · KWT
DePuy Orthopaedics, Inc.
Orthopedic · 24d
Cleared Jan 06, 1999
MODIFICATION OF TSRH SPINAL SYSTEM
K984522 · MNI
Danek Medical, Inc.
Orthopedic · 16d