ORTHOPEDIC SMOOTH PIN FIXATION— 510(k) K932348

Substantially Equivalent

Osteomed Corp.

FDA 510(k) clearance K932348 for ORTHOPEDIC SMOOTH PIN FIXATION, Substantially Equivalent on 1994-03-01. Applicant: Osteomed Corp..

Clearance details

Applicant: Osteomed Corp.
Product code: Code HTY
Advisory panel: Orthopedic
Date received: 1993-05-14
Decision date: 1994-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Wayne, IN, US

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Adverse events under product code HTY

product code HTY

Injury: 544
Total: 544

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.