Reform® POCT System— 510(k) K172495

Clearance details

Applicant

Precision Spine, Inc.

Product code

Code NKG

Device class

Class 2

Regulation

21 CFR 888.3075

Advisory panel

Orthopedic

Date received

2017-08-18

Decision date

2018-04-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Pear, MS, US

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Death

15

Injury

1,090

Malfunction

529

Total

1,634

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 →