Atlas FDA

VIPER SYSTEM, EXPEDIUM SYSTEM

FDA 510(k) clearance K101993 · decided 2010-12-07

Clearance details

K-number
K101993
Device name
VIPER SYSTEM, EXPEDIUM SYSTEM
Applicant
Depuy Spine, Inc.
Decision
Substantially Equivalent
Date received
2010-07-15
Decision date
2010-12-07
Days to decision
145 days
Clearance type
Special
Product code
NKB
Device class
2
Regulation number
888.3070
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Raynham, MA, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

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Recalls involving this device

RecordFirmDate
DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 Spinal Implant Compo recall (Z-0705-2013)DePuy Spine, Inc.2013-01-24
DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 Spinal Implant Compo recall (Z-0706-2013)DePuy Spine, Inc.2013-01-24
DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl Product Code: 1867-15-899 Spinal Implant Comp recall (Z-0707-2013)DePuy Spine, Inc.2013-01-24
DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl Product Code: 1867-15-970 Spinal Implant Compo recall (Z-0708-2013)DePuy Spine, Inc.2013-01-24
DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl Product Code: 1867-15-980 Spinal Implant Comp recall (Z-0709-2013)DePuy Spine, Inc.2013-01-24
DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl Product Code: 1867-15-999 Spinal Implant Comp recall (Z-0710-2013)DePuy Spine, Inc.2013-01-24
DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Spinal Implant Com recall (Z-0712-2013)DePuy Spine, Inc.2013-01-24
DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 Spinal Implant Comp recall (Z-0713-2013)DePuy Spine, Inc.2013-01-24

PMA approvals by this applicant

RecordFirmDate
IN MOTION LUMBAR ARTIFICIAL DISC (P040006/S005)Depuy Spine, Inc.2011-02-08
IN MOTION ARTIFICIAL DISC (P040006/S004)Depuy Spine, Inc.2007-09-05
CHARITE ARTIFICIAL DISC (P040006/S003)Depuy Spine, Inc.2006-12-15
CHARITE ARTIFICIAL DISC (P040006/S002)Depuy Spine, Inc.2006-03-29
CHARITE ARTIFICIAL DISC (P040006/S001)Depuy Spine, Inc.2005-06-16
CHARITE ARTIFICIAL DISC (P040006)Depuy Spine, Inc.2004-10-26
LUMBAR I/F CAGE SYSTEM (P960025/S010)Depuy Spine, Inc.2004-03-17
SABER LUMBAR I/F CAGE, JAGUAR LUMBAR I/F CAGE (P960025/S011)Depuy Spine, Inc.2004-03-05