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
13201–13224 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 20, 1999
EIS THREADED SCREW FRACTURE FIXATION
K991964 · HWC
Groupe Lepine
Orthopedic · 193d
Cleared Dec 20, 1999
LACTOSORB TRAUMA PLATING SYSTEM
K992355 · HRS
Biomet, Inc.
Orthopedic · 159d
Cleared Dec 20, 1999
SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEM
K993289 · KTT
Smith & Nephew, Inc.
Orthopedic · 80d
Cleared Dec 20, 1999
SADDLE SHAPED PATELLA
K993371 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 74d
Cleared Dec 20, 1999
OPUS SPINAL SYSTEM
K993402 · MNI
Howmedica Osteonics Corp.
Orthopedic · 73d
Cleared Dec 20, 1999
TITANIUM PEDIATRIC FEMORAL NAIL
K993956 · HSB
Biomet, Inc.
Orthopedic · 28d
Cleared Dec 20, 1999
ABSOLUTE ABSORBABLE INTERFERENCE SCREW
K993975 · HWC
Innovasive Devices, Inc.
Orthopedic · 26d
Cleared Dec 17, 1999
MULTITAK SS
K993115 · MAI
Bonutti Research, Inc.
Orthopedic · 88d
Cleared Dec 17, 1999
OMNIAXIAL CONNECTOR
K993926 · MNH
Ortho Tec, LLC
Orthopedic · 29d
Cleared Dec 15, 1999
BREMER HALO SYSTEM TITANIUM SKULL PIN
K993099 · JEC
Depuyacromed
Orthopedic · 90d
Cleared Dec 15, 1999
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
K993855 · KWQ
Danek Medical, Inc.
Orthopedic · 30d
Cleared Dec 14, 1999
EBI XFIX VISION FIXATION SYSTEM
K993886 · KTT
Ebi, L.P.
Orthopedic · 28d
Cleared Dec 10, 1999
SMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 531525
K993074 · MAI
Bionx Implants, Ltd.
Orthopedic · 87d
Cleared Dec 10, 1999
ENDOPEARL WITH THREADER
K993339 · MAI
Linvatec Corp.
Orthopedic · 66d
Cleared Dec 10, 1999
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
K993822 · KWQ
Ebi, L.P.
Orthopedic · 28d
Cleared Dec 09, 1999
SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND ACCESSORIES)
K993106 · HRS
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared Dec 08, 1999
NEXFLEX TOTAL KNEE SYSTEM
K991882 · JWH
Nexmed, Inc.
Orthopedic · 189d
Cleared Dec 06, 1999
SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030,...
K993073 · MAI
Bionx Implants, Ltd.
Orthopedic · 83d
Cleared Dec 06, 1999
SYNERGY INTEGRAL SCREWS, MODEL NUMBERS...
K993808 · MNH
Interpore Cross Intl.
Orthopedic · 26d
Cleared Dec 02, 1999
AED ARTHROSCOPE
K991656 · HRX
National Advanced Endoscopy Devices,...
Orthopedic · 203d
Cleared Dec 02, 1999
MS-30 FEMORAL STEM
K993043 · LZO
Sulzer Orthopedics, Inc.
Orthopedic · 83d
Cleared Dec 02, 1999
TALON ANCHOR SNAP-PAK
K993261 · MBI
Mitek Products
Orthopedic · 64d
Cleared Dec 02, 1999
DURACON INSET PATELLA, 25MM
K993692 · JWH
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Dec 01, 1999
APR METASUL ACETABULAR INSERT
K993569 · KWA
Sulzermedica
Orthopedic · 41d