PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549)— 510(k) K091725

Substantially Equivalent

U&I Corp.

FDA 510(k) clearance K091725 for PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549), Substantially Equivalent on 2009-11-09. Applicant: U&I Corp..

Clearance details

Applicant: U&I Corp.
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 2009-06-11
Decision date: 2009-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uijungbu, Gyeonggi-Do, KR

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Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.