FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,850 results
12913–12936 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 05, 2001
TRIOLOGY ACETABULAR SYSTEM 46MM LARGE HEAD LINERS, MODEL 6310
K003478 · LPH
Zimmer, Inc.
Orthopedic · 88d
Cleared Feb 05, 2001
ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS
K010081 · KWY
Exactech, Inc.
Orthopedic · 26d
Cleared Jan 31, 2001
EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM
K010003 · KWQ
Ebi, L.P.
Orthopedic · 29d
Cleared Jan 29, 2001
COLLES C SERIES FRAME STERILE PACK
K003397 · KTT
DePuy Orthopaedics, Inc.
Orthopedic · 89d
Cleared Jan 26, 2001
SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT AND ACM AND MIXEVACII
K002652 · LOD
Stryker Corp.
Orthopedic · 154d
Cleared Jan 25, 2001
FMP METAL/METAL ACETABULAR INSERT
K003250 · KWA
Encore Orthopedics, Inc.
Orthopedic · 100d
Cleared Jan 25, 2001
IMPLEX CONTINUUM KNEE SYSTEM-PATELLAR COMPONENTS, MODEL 04-XX-YYYYY
K004013 · JWH
Implex Corp.
Orthopedic · 29d
Cleared Jan 24, 2001
PARSFIX CABLE-SCREW SYSTEM
K003351 · KWP
Spinal Concepts, Inc.
Orthopedic · 90d
Cleared Jan 19, 2001
OTI CERAMIC FEMORAL HEAD SYSTEM
K003316 · LZO
Osteoimplant Technology, Inc.
Orthopedic · 88d
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