Restoration Anatomic Shell— 510(k) K210893

Clearance details

Applicant

Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics

Product code

Code LPH

Device class

Class 2

Regulation

21 CFR 888.3358

Advisory panel

Orthopedic

Date received

2021-03-25

Decision date

2021-04-22

Decision

Substantially Equivalent

Clearance type

Special

Location

Mahwah, NJ, 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 →