GAP ENDO-EXO MEDULLARY SYSTEM— 510(k) K111232

Substantially Equivalent

Pega Medical, Inc.

FDA 510(k) clearance K111232 for GAP ENDO-EXO MEDULLARY SYSTEM, Substantially Equivalent on 2012-01-26. Applicant: Pega Medical, Inc..

Clearance details

Applicant: Pega Medical, Inc.
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 2011-05-02
Decision date: 2012-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laval, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code HSB

product code HSB

Death: 49
Injury: 12,083
Malfunction: 6,561
Other: 1
Total: 18,694

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.