PRECICE Plating System— 510(k) K192181

Clearance details

Applicant

Nuvasive Specialized Orthopedics, Inc.

Product code

Code KTT

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

2019-08-12

Decision date

2019-11-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Alisa Viejo, CA, US

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Death

11

Injury

3,097

Malfunction

1,261

Total

4,369

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-1325-2021 — PRECICE PLATE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.Class II·Ongoing·Nuvasive Specialized Orthopedics Inc·20210212

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K192181.