RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEM— 510(k) K132312

Clearance details

Applicant

Renovis Surgical Technologies, LLC

Product code

Code LPH

Device class

Class 2

Regulation

21 CFR 888.3358

Advisory panel

Orthopedic

Date received

2013-07-25

Decision date

2014-04-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Ashland, MA, US

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Death

73

Injury

31,640

Malfunction

3,358

Other

2

Total

35,073

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 →