EXTERNAL FIXATION CLAMP 5.0 MM PIN X9.5MM ROD, MODEL 1151-100, EXTERNAL FIXATON CLAMP, 9.5MM ROD— 510(k) K080408

Clearance details

Applicant

Advanced Orthopaedic Solutions, Inc.

Product code

Code KTT

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

2008-02-14

Decision date

2008-04-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Torrance, 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 →