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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,816 results
10897–10920 of 17,816
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Sep 06, 2005
MIOT PLATING SYSTEM
K051945 · HRS
Orthofix Srl
Orthopedic · 50d
Cleared Sep 06, 2005
POROUS COATED DISCOVERY ELBOW
K051975 · JDC
Biomet, Inc.
Orthopedic · 47d
Cleared Sep 06, 2005
R&R EXTERNAL FIXATION SYSTEM
K052005 · KTT
R&R Medical, Inc.
Orthopedic · 43d
Cleared Sep 06, 2005
SC CERAMIC BALL HEADS
K052237 · LZO
Orthopedic Alliance, LLC
Orthopedic · 20d
Cleared Aug 31, 2005
TRIABSORB COMPOSITE SCREW
K050468 · HWC
Advanced Biomaterials
Orthopedic · 189d
Cleared Aug 31, 2005
ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER
K052086 · PHX
Encore Medical, Inc.
Orthopedic · 29d
Cleared Aug 31, 2005
TSRH SPINAL SYSTEM
K052144 · NKB
Medtronic Sofamor Danek
Orthopedic · 23d
Cleared Aug 30, 2005
TRIATHLON PRESS-FIT TOTAL KNEE SYSTEM
K051380 · MBH
Howmedica Osteonics Corp.
Orthopedic · 95d
Cleared Aug 29, 2005
U1 HIP SYSTEM - BIPOLAR
K050269 · KWY
United Orthopedic Corp.
Orthopedic · 206d
Cleared Aug 29, 2005
THE SC-ACUFIX ANT-CER DYNAMIC CERVICAL PLATE SYSTEM SINGLE LEVEL PLATES
K052072 · KWQ
Abbott Spine, Inc.
Orthopedic · 28d
Cleared Aug 26, 2005
SIJF CANNULATED SCREW SYSTEM
K051296 · OUR
Depuy Spine, Inc.
Orthopedic · 100d
Cleared Aug 25, 2005
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
K052062 · KTT
Alliance Medical Corp.
Orthopedic · 27d
Cleared Aug 25, 2005
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
K052064 · KTT
Alliance Medical Corp.
Orthopedic · 27d
Cleared Aug 25, 2005
MATRYX INTERFERENCE SCREW
K052080 · HWC
Linvatec Biomaterials, Inc.
Orthopedic · 23d
Cleared Aug 24, 2005
UNIGLIDE UNICONDYLAR KNEE PROSTHESIS
K050764 · HRY
Corin USA
Orthopedic · 153d
Cleared Aug 23, 2005
APTUS TITANIUM OSTEOSYNTHESIS SYSTEM
K051567 · HRS
Medartis, Inc.
Orthopedic · 70d
Cleared Aug 23, 2005
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K052180 · KWP
Medtronic Sofamor Danek
Orthopedic · 13d
Cleared Aug 22, 2005
FR.O.H. CALCANEUS REPAIR SYSTEM
K051642 · NDF
I.T.S. Implantat-Technologie-Systeme...
Orthopedic · 63d
Cleared Aug 22, 2005
PROFEMUR RENAISSANCE HIP STEM
K051995 · JDL
Wrightmedicaltechnologyinc
Orthopedic · 28d
Cleared Aug 22, 2005
MODIFICATION TO: TITANIUM TELEGRAPH HUMERAL NAIL
K052058 · HSB
Fournitures Hospitalieres Industrie
Orthopedic · 24d
Cleared Aug 22, 2005
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
K052065 · KTT
Alliance Medical Corp.
Orthopedic · 24d
Cleared Aug 22, 2005
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K052187 · NKB
Medtronic Sofamor Danek
Orthopedic · 11d
Cleared Aug 19, 2005
CONSERVE TOTAL FEMORAL HEAD
K051348 · JDL
Wrightmedicaltechnologyinc
Orthopedic · 87d
Cleared Aug 18, 2005
MODIFICATION TO: XIA STAINLESS STEEL SYSTEM
K051973 · KWP
Stryker Spine
Orthopedic · 28d