MECTALIF TIPEEK— 510(k) K133192

Clearance details

Applicant

Medacta International

Product code

Code MAX

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2013-10-17

Decision date

2014-01-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Camarillo, CA, US

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• K153664 — M.U.S.T. Pedicle Screw System2016-01-19
• K151531 — MasterLoc Stem2015-10-30
• K142744 — Mecta-C TiPEEK2015-05-07

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 →