DePuy Spine, Inc.

FDA Regulatory Profile

DePuy Spine, Inc. appears in FDA public data with 36 recalls, 71 510(k) clearances, 9 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1323-2022, Class II) was initiated on May 20, 2022. Its most recent 510(k) clearance was granted on Oct 15, 2022.

Summary

Total Recalls
36
510(k) Clearances
71
Inspections
9
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1323-2022Class IIEIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autogrMay 20, 2022
Z-1324-2022Class IIEIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use with autogrMay 20, 2022
Z-1225-2019Class IIConcorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (19Apr 8, 2019
Z-1226-2019Class IIConcorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (197809023L), 9x27 (Apr 8, 2019
Z-1300-2018Class IIConfidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 28Dec 15, 2017
Z-0630-2017Class IIDePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW 4.5 x 18mm Item CodeOct 12, 2016
Z-0627-2017Class IIDePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 26mm Item CodOct 12, 2016
Z-0625-2017Class IIDePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Item CoOct 12, 2016
Z-0628-2017Class IIDePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW 4.5 x 18mm Item Code: Oct 12, 2016
Z-0629-2017Class IIDePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING SCREW 4 x 18mm Item CoOct 12, 2016
Z-0624-2017Class IIDePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Item COct 12, 2016
Z-0626-2017Class IIDePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 20mm Item CodeOct 12, 2016
Z-0454-2016Class IIAegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS AnterNov 20, 2015
Z-1674-2015Class IIEXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 175Apr 21, 2015
Z-0097-2014Class IIPIPELINE LS ACCESS SYSTEM, Holding Clip The PIPELINE LS Dilators and Holding Clip are intended foJul 31, 2013
Z-0093-2014Class IIPIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and Holding Clip aJul 31, 2013
Z-0095-2014Class IIPIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and Holding ClipJul 31, 2013
Z-0096-2014Class IIPIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS Dilators and Holding CliJul 31, 2013
Z-0094-2014Class IIPIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS Dilators and Holding CliJul 31, 2013
Z-2134-2013Class IICONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFIDENCE Spinal Cement SysApr 17, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K222276CONDUIT Cages; FIBERGRAFT BG PuttyOct 15, 2022
K201831CONFIDENCE Spinal Cement SystemAug 31, 2020
K142185EXPEDIUM VERSE SPINE SYSTEMNov 19, 2014
K111136EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEMJun 14, 2012
K121020VIPER SYSTEMMay 3, 2012
K110353MOUNTAINEER OCT SPINAL SYSTEMApr 7, 2011
K110216EXPEDIUM SYSTEM, VIPER SYSTEMApr 1, 2011
K103133VEPER SYSTEM, EXPEDIUM SYSTEMJan 18, 2011
K101993VIPER SYSTEM, EXPEDIUM SYSTEMDec 7, 2010
K101923CONCORDE CURVE SYSTEMDec 1, 2010
K103100MOUNTAINEER OCT SPINAL SYSTEMNov 17, 2010
K101762VIPER F2 FACET FIXATION SYSTEMNov 15, 2010
K102701VIPER SPINE SYSTEMOct 20, 2010
K101933MODIFICATION TO:EXPEDIUM SPINE SYSTEMOct 18, 2010
K093390HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025May 25, 2010
K100070UNIPLATE ANTERIOR CERVICAL PLATE SYSTEMFeb 4, 2010
K091994MOUNTAINEER LAMINOPLASTY SYSTEMJan 7, 2010
K092473EXPEDIUM SPINE SYSTEMNov 25, 2009
K092626MODIFICATION TO: EXPEDIUM SPINE SYSTEMSep 25, 2009
K090648VIPER 2 SYSTEMJun 10, 2009