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
12217–12240 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 24, 2002
CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE
K021466 · LPH
Hayes Medical, Inc.
Orthopedic · 78d
Cleared Jul 24, 2002
CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENT
K021499 · LOD
DePuy Orthopaedics, Inc.
Orthopedic · 76d
Cleared Jul 24, 2002
MODIFICATION TO TOWNLEY TRANSFACEPEDICULAR SCREW FIXATION SYSTEM
K021705 · MRW
Medtronic Sofamor Danek, Inc.
Orthopedic · 62d
Cleared Jul 24, 2002
MPF ACETABULAR CUP GENERATION 2
K022120 · LZO
Plus Orthopedics
Orthopedic · 23d
Cleared Jul 24, 2002
MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
K022190 · MNI
Depuyacromed
Orthopedic · 19d
Cleared Jul 23, 2002
ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM
K020356 · MNH
Alphatec Mfg., Inc.
Orthopedic · 169d
Cleared Jul 23, 2002
R120 MODULAR TOTAL HIP SYSTEM
K021822 · JDI
Osteoimplant Technology, Inc.
Orthopedic · 49d
Cleared Jul 22, 2002
OPUS MAGNUM ANCHOR & INSTRUMENT SET
K020172 · MBI
Opus Medical, Inc.
Orthopedic · 186d
Cleared Jul 22, 2002
COLORADO 2 SPINAL SYSTEM
K020247 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 179d
Cleared Jul 22, 2002
MASTERGRAFT RESORBABLE CERAMIC
K020986 · MQV
Medtronic Sofamor Danek, Inc.
Orthopedic · 117d
Cleared Jul 22, 2002
SEARCH EVOLUTION TOTAL KNEE SYSTEM
K021313 · JWH
Aesculap, Inc.
Orthopedic · 88d
Cleared Jul 22, 2002
ATLANTIS VISION ANTERIOR CERVICAL PLATE SYSTEM
K021461 · KWQ
Medtronic Sofamor Danek
Orthopedic · 76d
Cleared Jul 22, 2002
XANTUS ANTERIOR LATERAL SUPPLEMENTAL FIXATION SYSTEM
K022070 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 26d
Cleared Jul 18, 2002
MICOMED POSTERIOR DOUBLEROD SYSTEM
K021275 · MNI
Micomed Ortho GmbH
Orthopedic · 87d
Cleared Jul 18, 2002
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K022015 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Jul 17, 2002
HLS NOETOS SYSTEM
K013906 · JWH
Tornier
Orthopedic · 233d
Cleared Jul 17, 2002
LACTOSORB MINI INTERFERENCE SCREW
K021254 · HWC
Biomet Orthopedics, Inc.
Orthopedic · 89d
Cleared Jul 17, 2002
INION HEXALON BIODEGRADABLE ACL/PCL SCREW
K021280 · HWC
Inion , Ltd.
Orthopedic · 86d
Cleared Jul 17, 2002
WRIST FUSION PLATE
K021321 · HRS
Acu Med, Inc.
Orthopedic · 83d
Cleared Jul 17, 2002
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODELS 06-112-00XX2 AND 06-132-10XX2
K021967 · MQP
Implex Corp.
Orthopedic · 30d
Cleared Jul 12, 2002
3D KNEE
K020114 · JWH
Encore Orthopedics, Inc.
Orthopedic · 182d
Cleared Jul 12, 2002
THE TRABECULAR METAL MONOBLOCK CUP, MODELS 00-7259-0XX-28 (ZIMMER CAT. #) AND...
K021970 · LPH
Implex Corp.
Orthopedic · 25d
Cleared Jul 11, 2002
AMC ANTIMICROBIAL PIN/WIRE SLEEVE
K012193 · JEC
Smith & Nephew, Inc.
Orthopedic · 364d
Cleared Jul 11, 2002
MONARCH SPINE SYSTEM
K021335 · MNH
Depuyacromed
Orthopedic · 76d