XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory— 510(k) K152632

Clearance details

Applicant

Stryker Corporation

Product code

Code NKB

Device class

Class 2

Regulation

21 CFR 888.3070

Advisory panel

Orthopedic

Date received

2015-09-15

Decision date

2015-12-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Allendale, NJ, US

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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 →