CONCORDE BULLET SPINAL SYSTEM— 510(k) K110694

Clearance details

Applicant

Johnson & Johnson

Product code

Code MAX

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2011-03-14

Decision date

2011-10-11

Decision

Substantially Equivalent

Clearance type

Special

Location

Raynham, MA, US

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• K113273 — SPOTLIGHT ACCESS SYSTEM2012-01-27
• K112913 — SPOTLIGHT ACCESS SYSTEM2011-12-16
• K113348 — COUGAR SYSTEM2011-12-13
• K110551 — EXPEDIUM SPINE SYSTEM2011-10-26
• K111571 — VIPER SYSTEMS2011-07-06

Death

13

Injury

1,305

Malfunction

2,885

Total

4,203

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 →