FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

41 results for "Sofamor Danek USA,Inc."
25–41 of 41
Search insights Median review: 141d Cleared: 100% Top manufacturer: Sofamor Danek USA,Inc. Lead specialty: Orthopedic
Cleared Feb 06, 1997
TITANIUM CD HORIZON SPINAL SYSTEM
K962708 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 209d
Cleared Jan 14, 1997
ALPHA POSTERIOR SPINAL SYSTEM
K964275 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 81d
Cleared Dec 05, 1996
CD HORIZON SPINAL SYSTEM
K961633 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 220d
Cleared Nov 27, 1996
CD HORIZON ANTERIOR SPINAL SYSTEM
K963655 · KWQ
Sofamor Danek USA,Inc.
Orthopedic · 76d
Cleared Oct 01, 1996
COTREL-DUBOUSSET (CD) SPINAL
K955807 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 284d
Cleared Mar 27, 1996
COMPACT COTREL-DUBOUSSET (CCD) SPINAL SYSTEM
K955365 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 126d
Cleared Feb 14, 1996
AUGMENT-T POSTERIOR SPINAL SYSTEM
K950717 · MNH
Sofamor Danek USA,Inc.
Orthopedic · 363d
Cleared Feb 09, 1996
CD LIBERTY POSTERIOR SPINCAL SYSTEM
K951164 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 332d
Cleared Jan 16, 1996
TITANIUM GDLH POSTERIOR SPINAL SYSTEM
K954645 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 98d
Cleared Dec 18, 1995
INCL ENDOSCOPE
K955471 · HRX
Sofamor Danek USA,Inc.
Orthopedic · 69d
Cleared Nov 21, 1995
INCLUSICE II(TM) ENDOSCOPE
K946087 · HRX
Sofamor Danek USA,Inc.
Orthopedic · 343d
Cleared Oct 30, 1995
TITANIUM DYNA-LOK SPINAL SYSTEM
K953635 · MNH
Sofamor Danek USA,Inc.
Orthopedic · 89d
Cleared Aug 28, 1995
GDLH POSTERIOR SPINAL SYSTEM
K950596 · MNH
Sofamor Danek USA,Inc.
Orthopedic · 200d
Cleared Aug 25, 1995
PARAGON POSTERIOR SPINAL SYSTEM
K950955 · MNH
Sofamor Danek USA,Inc.
Orthopedic · 176d
Cleared Aug 07, 1995
TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS)
K946348 · MNH
Sofamor Danek USA,Inc.
Orthopedic · 220d
Cleared May 12, 1995
DANEK RIGID ARTHROSCOPE
K950501 · HRX
Sofamor Danek USA,Inc.
Orthopedic · 95d
Cleared May 01, 1995
MICRO-ENDO(TM) INSTRUMENTS
K950130 · HRX
Sofamor Danek USA,Inc.
Orthopedic · 109d