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
12889–12912 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 20, 2001
PLGA PIN, MODEL...
K003659 · HTY
Bionx Implants, Inc.
Orthopedic · 84d
Cleared Feb 20, 2001
SYNTHES HAMSTRING LOOP
K003700 · HWC
Synthes (Usa)
Orthopedic · 81d
Cleared Feb 15, 2001
ENHANCED POLYETHYLENE KNEE PROSTHESES
K001147 · JWH
Howmedica Osteonics Corp.
Orthopedic · 311d
Cleared Feb 15, 2001
MITEK 2GII MENISCAL REPAIR SYSTEM
K002406 · MAI
Mitek Products
Orthopedic · 192d
Cleared Feb 15, 2001
DYONICS CONTROL RF SYSTEM
K003572 · HRX
Smith & Nephew, Inc.
Orthopedic · 87d
Cleared Feb 15, 2001
SMITH & NEPHEW SUTURE ANCHOR
K003599 · HWC
Smith & Nephew, Inc.
Orthopedic · 86d
Cleared Feb 15, 2001
PERFECTA AND EXTEND
K004032 · LPH
Wrightmedicaltechnologyinc
Orthopedic · 49d
Cleared Feb 15, 2001
TRI-FIT FEMORAL STEM
K010243 · LWJ
Corin USA
Orthopedic · 21d
Cleared Feb 14, 2001
COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS
K003566 · KWS
Smith & Nephew, Inc.
Orthopedic · 86d
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