TRANSCORP SPINAL ACCESS SYSTEM— 510(k) K113352

Substantially Equivalent

Transcorp, Inc.

FDA 510(k) clearance K113352 for TRANSCORP SPINAL ACCESS SYSTEM, Substantially Equivalent on 2012-04-16. Applicant: Transcorp, Inc..

Clearance details

Applicant: Transcorp, Inc.
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2011-11-14
Decision date: 2012-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Byron Center, MI, US

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Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.