Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

440 results for "Medtronic Sofamor Danek"
313–336 of 440
Search insights Median review: 67d Cleared: 100% Top manufacturer: Medtronic Sofamor Danek USA, Inc. Lead specialty: Orthopedic
Cleared Feb 03, 2005
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K043321 · NKB
Medtronic Sofamor Danek
Orthopedic · 63d
Cleared Feb 01, 2005
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K043151 · KWQ
Medtronic Sofamor Danek
Orthopedic · 78d
Cleared Feb 01, 2005
GAPP GRAFT CONTIANMENT DEVICE ORTHOPEDICS
K031782 · KWQ
Medtronic Sofamor Danek
Orthopedic · 602d
Cleared Jan 25, 2005
EQUESTRA FLUID DELIVERY SYSTEM
K043568 · HRX
Medtronic Sofamor Danek
Orthopedic · 29d
Cleared Jan 07, 2005
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K043566 · MQP
Medtronic Sofamor Danek
Orthopedic · 11d
Cleared Jan 07, 2005
GLAXY 3.2 SPINAL SYSTEM
K043020 · KWP
Medtronic Sofamor Danek
Orthopedic · 65d
Cleared Dec 29, 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K043561 · MQP
Medtronic Sofamor Danek
Orthopedic · 2d
Cleared Dec 28, 2004
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K043343 · MNH
Medtronic Sofamor Danek
Orthopedic · 22d
Cleared Dec 21, 2004
VERTEX RECONSTRUCTION SYSTEM
K042789 · KWP
Medtronic Sofamor Danek
Orthopedic · 76d
Cleared Dec 14, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K042962 · NKB
Medtronic Sofamor Danek
Orthopedic · 48d
Cleared Nov 19, 2004
VENTURE ANTERIOR CERVICAL PLATING SYSTEM
K042922 · KWQ
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Nov 18, 2004
CD HORIZON SPINAL SYSTEM
K042886 · NKB
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Nov 04, 2004
CD HORIZON SPINAL SYSTEM
K042790 · NKB
Medtronic Sofamor Danek
Orthopedic · 29d
Cleared Nov 04, 2004
MSD SILO SPINAL SYSTEM
K042210 · MNI
Medtronic Sofamor Danek
Orthopedic · 80d
Cleared Oct 08, 2004
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K042524 · KWP
Medtronic Sofamor Danek
Orthopedic · 21d
Cleared Oct 07, 2004
ORION ANTERIOR CERVICAL PLATING SYSTEM
K042499 · KWQ
Medtronic Sofamor Danek
Orthopedic · 23d
Cleared Oct 07, 2004
VERTEX RECONSTRUCTION SYSTEM
K042498 · KWP
Medtronic Sofamor Danek
Orthopedic · 23d
Cleared Oct 07, 2004
MODIFICATION TO EQUATION FIXATION SYSTEM
K042453 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared Oct 01, 2004
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K042402 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Sep 17, 2004
ORION ANTERIOR CERVICAL PLATING SYSTEM
K042235 · KWQ
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Sep 15, 2004
CD HORIZON SPINAL SYSTEM
K041862 · KWP
Medtronic Sofamor Danek
Orthopedic · 68d
Cleared Sep 08, 2004
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K042167 · NKB
Medtronic Sofamor Danek
Orthopedic · 28d
Cleared Sep 03, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K041777 · MNI
Medtronic Sofamor Danek
Orthopedic · 64d
Cleared Aug 25, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K042025 · KWQ
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d