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"
337–360 of 440
Search insights Median review: 67d Cleared: 100% Top manufacturer: Medtronic Sofamor Danek USA, Inc. Lead specialty: Orthopedic
Cleared Aug 09, 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K041197 · MQP
Medtronic Sofamor Danek
Orthopedic · 94d
Cleared Jul 23, 2004
EQUESTRA FLUID DELIVERY SYSTEM
K040483 · HRX
Medtronic Sofamor Danek, Inc.
Orthopedic · 149d
Cleared Jul 07, 2004
HOURGLASS VERTEBRAL BODY SPACER
K033926 · MQP
Medtronic Sofamor Danek
Orthopedic · 202d
Cleared Jul 01, 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K041556 · MQP
Medtronic Sofamor Danek
Orthopedic · 21d
Cleared Jul 01, 2004
CD HORIZON SPINAL SYSTEM
K041460 · KWQ
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Jun 30, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K041030 · MNI
Medtronic Sofamor Danek
Orthopedic · 70d
Cleared Jun 24, 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K041452 · MQP
Medtronic Sofamor Danek
Orthopedic · 23d
Cleared Jun 10, 2004
MODIFICATION TO TSRH SPINAL SYSTEM
K041282 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared May 28, 2004
MODIFICATION TO BONE GRAFT WASHER
K041217 · KWQ
Medtronic Sofamor Danek, Inc.
Orthopedic · 18d
Cleared May 28, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K041118 · MNI
Medtronic Sofamor Danek
Orthopedic · 29d
Cleared May 14, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K040962 · KWQ
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared May 05, 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K040536 · MQP
Medtronic Sofamor Danek
Orthopedic · 64d
Cleared Apr 21, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K034056 · MNH
Medtronic Sofamor Danek
Orthopedic · 113d
Cleared Mar 31, 2004
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K040583 · MNI
Medtronic Sofamor Danek
Orthopedic · 26d
Cleared Mar 19, 2004
MODIFICATION TO VERTE-STACK
K040422 · MQP
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Mar 09, 2004
ARROWHEAD SPINAL SYSTEM
K032560 · NKB
Medtronic Sofamor Danek
Orthopedic · 202d
Cleared Feb 18, 2004
VERTE-STACK SPINAL SYSTEM
K040167 · MQP
Medtronic Sofamor Danek
Orthopedic · 23d
Cleared Feb 12, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K040072 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 29d
Cleared Dec 15, 2003
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K033322 · MNH
Medtronic Sofamor Danek
Orthopedic · 61d
Cleared Dec 03, 2003
MODIFICATION TO EQUATION FIXATION SYSTEM
K033495 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Nov 06, 2003
DYNALOK CLASSIC SPINAL SYSTEM
K033271 · MNI
Medtronic Sofamor Danek
Orthopedic · 27d
Cleared Sep 17, 2003
TSRH SPINAL SYSTEM
K032578 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared Sep 17, 2003
TSRH SPINAL SYSTEM
K031967 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 83d
Cleared Sep 12, 2003
CD HORIZON SPINAL SYSTEM
K032033 · NKB
Medtronic Sofamor Danek
Orthopedic · 73d