VIPER SYSTEM, EXPEDIUM SYSTEM— 510(k) K101993

Clearance details

Applicant

Depuy Spine, Inc.

Product code

Code NKB

Device class

Class 2

Regulation

21 CFR 888.3070

Advisory panel

Orthopedic

Date received

2010-07-15

Decision date

2010-12-07

Decision

Substantially Equivalent

Clearance type

Special

Location

Raynham, MA, US

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• K253943 — Tiger 2 System2026-07-24
• K260362 — QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)2026-07-24
• K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System2026-07-14
• K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD2026-07-01

• K201831 — CONFIDENCE Spinal Cement System2020-08-31
• K142185 — EXPEDIUM VERSE SPINE SYSTEM2014-11-19
• K111136 — EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM2012-06-14
• K121020 — VIPER SYSTEM2012-05-03
• K110353 — MOUNTAINEER OCT SPINAL SYSTEM2011-04-07

Death

27

Injury

5,033

Malfunction

4,140

Total

9,200

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0705-2013 — DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 Spinal Implant Component.Class II·Terminated·DePuy Spine, Inc.·20121107
• Z-0706-2013 — DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 Spinal Implant Component.Class II·Terminated·DePuy Spine, Inc.·20121107
• Z-0707-2013 — DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl Product Code: 1867-15-899 Spinal Implant Component.Class II·Terminated·DePuy Spine, Inc.·20121107
• Z-0708-2013 — DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl Product Code: 1867-15-970 Spinal Implant Component.Class II·Terminated·DePuy Spine, Inc.·20121107
• Z-0709-2013 — DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl Product Code: 1867-15-980 Spinal Implant Component.Class II·Terminated·DePuy Spine, Inc.·20121107
• Z-0710-2013 — DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl Product Code: 1867-15-999 Spinal Implant Component.Class II·Terminated·DePuy Spine, Inc.·20121107
• Z-0712-2013 — DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Spinal Implant Component.Class II·Terminated·DePuy Spine, Inc.·20121107
• Z-0713-2013 — DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 Spinal Implant Component.Class II·Terminated·DePuy Spine, Inc.·20121107

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101993.