F1 MPS Modular Pedicle Screw System— 510(k) K160926

Clearance details

Applicant

Degen Medical

Product code

Code NKB

Device class

Class 2

Regulation

21 CFR 888.3070

Advisory panel

Orthopedic

Date received

2016-04-04

Decision date

2016-06-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Florence, SC, 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 →