FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Orthopedic ×
17,985 results
13057–13080 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 17, 2001
TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM
K003928 · MRW
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Jan 12, 2001
BIOMET'S MINIMALLY CONSTRAINED ELBOW
K003253 · JDC
Biomet, Inc.
Orthopedic · 87d
Cleared Jan 12, 2001
CONTOUR LABRAL NAIL, MODEL 533520A
K003970 · MAI
Bionx Implants, Inc.
Orthopedic · 21d
Cleared Jan 12, 2001
MAXIM KNEE SYSTEM
K010027 · JWH
Biomet, Inc.
Orthopedic · 9d
Cleared Jan 11, 2001
LACTOSORB SCREW ANCHOR
K003273 · MAI
Biomet, Inc.
Orthopedic · 85d
Cleared Jan 11, 2001
HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST
K003848 · JEC
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Jan 10, 2001
TRIAD II MODULAR TOTAL HIP SYSTEM
K003199 · LPH
Osteoimplant Technology, Inc.
Orthopedic · 90d
Cleared Jan 10, 2001
U2 HIP STEM, TI POROUS COATED
K003237 · LPH
United Orthopedic Corp.
Orthopedic · 85d
Cleared Jan 08, 2001
BIO-ABSORBABLE CORKSCREW MODEL AR-1920B
K003227 · MAI
Arthrex, Inc.
Orthopedic · 84d
Cleared Jan 08, 2001
ISOLA CLOSED DUAL ROD CONNECTOR
K003822 · KWP
Depuyacromed
Orthopedic · 28d
Cleared Jan 04, 2001
VERTEBRAL BODY REPLACEMENT
K003155 · MQP
Osteotech, Inc.
Orthopedic · 86d
Cleared Jan 04, 2001
UNICONDYLAR INTERPOSITIONAL SPACER
K003269 · HSH
Sulzer Orthopedics, Inc.
Orthopedic · 78d
Cleared Jan 04, 2001
SULZER ORTHOPEDICS ANATOMICAL SHOULDER CEMENTED HUMERAL STEM
K003832 · KWS
Sulzer Orthopedics, Inc.
Orthopedic · 24d
Cleared Jan 04, 2001
EBI VUECATH SPINAL ENDOSCOPIC SYSTEM
K003898 · HRX
Ebi, L.P.
Orthopedic · 17d
Cleared Jan 02, 2001
MODIFICATION TO EBI SPINELINK SYSTEM
K003764 · MNH
Ebi, L.P.
Orthopedic · 27d
Cleared Dec 29, 2000
BIOMET EXTERNAL WRIST PLATE
K003240 · LXT
Biomet, Inc.
Orthopedic · 73d
Cleared Dec 28, 2000
FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
K003212 · JDS
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 76d
Cleared Dec 27, 2000
MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
K003215 · JDS
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 75d
Cleared Dec 22, 2000
CD HORIZON SPINAL SYSTEM
K000641 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 301d
Cleared Dec 20, 2000
MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM
K003728 · KWS
Tornier
Orthopedic · 16d
Cleared Dec 18, 2000
DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM
K002923 · LXT
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Dec 15, 2000
SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
K002733 · KWP
Depuyacromed
Orthopedic · 105d
Cleared Dec 15, 2000
REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
K002747 · LPH
Smith & Nephew, Inc.
Orthopedic · 101d
Cleared Dec 15, 2000
TITAN TIBIAL NAIL
K003018 · HSB
Howmedica Osteonics Corp.
Orthopedic · 79d