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
13033–13056 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 14, 2001
MICROSCOPE-STAINLESS STEEL/FIBER OPTIC: .5-2.6MM MODEL MMD 4500 SERIES AND...
K003695 · HRX
Micro-Medical Devices, Inc.
Orthopedic · 76d
Cleared Feb 14, 2001
TITANIUM CEMENT RESTRICTOR (TCR)
K003718 · JDK
Medtronic Sofamor Danek, Inc.
Orthopedic · 72d
Cleared Feb 14, 2001
OFFSET TIBIAL TRAY
K010212 · MBV
Biomet, Inc.
Orthopedic · 22d
Cleared Feb 14, 2001
KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP,...
K010246 · HRX
Kyphon, Inc.
Orthopedic · 19d
Cleared Feb 09, 2001
SYNTHES MODIFIED BIORESORBABLE SUTURE ANCHOR SYSTEM
K003743 · MAI
Synthes (Usa)
Orthopedic · 67d
Cleared Feb 09, 2001
AML HIP PROSTHESIS
K003800 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 63d
Cleared Feb 09, 2001
MODIFICATION TO EXACTECH ACUMATCH INTEGRATED HIP SYSTEM, M-SERIES HIGH...
K010120 · LPH
Exactech, Inc.
Orthopedic · 24d
Cleared Feb 09, 2001
STERILE BUTTON PLATE
K010121 · MBI
Synthes (Usa)
Orthopedic · 24d
Cleared Feb 09, 2001
EBI VUECATH SPINAL ENDOSCOPIC SYSTEM
K010179 · HRX
Ebi, L.P.
Orthopedic · 21d
Cleared Feb 09, 2001
LATERAL OFFSET PROTRACT PRESS FIT HIP STEM
K010282 · LPH
Stelkast Company
Orthopedic · 10d
Cleared Feb 08, 2001
CEMEX SYSTEM GUN APPLICATION VERSION
K000943 · LOD
Exactech, Inc.
Orthopedic · 322d
Cleared Feb 08, 2001
CANNULATED SCREW SYSTEM
K003496 · HTN
Pioneer Surgical Technology
Orthopedic · 87d
Cleared Feb 08, 2001
BIOLOK SCREW, BIOSTEON SCREW
K003641 · HWC
Biocomposites, Ltd.
Orthopedic · 73d
Cleared Feb 08, 2001
TAPER-FIT TOTAL HIP SYSTEM
K003666 · JDI
Corin USA
Orthopedic · 72d
Cleared Feb 08, 2001
PROTRACT PRESS FIT HIP STEM-HA COATED
K010241 · LPH
Stelkast Company
Orthopedic · 14d
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