VSP (VARIABLE SCREW PLACEMENT) SPINAL FIXATION SYSTEM, PEDICLE SCREW(S), SPINE PLATE(S), WASHER(S) & NUT(S)— 510(k) K951657

Substantially Equivalent for Some Indications

Acromed Corp.

FDA 510(k) clearance K951657 for VSP (VARIABLE SCREW PLACEMENT) SPINAL FIXATION SYSTEM, PEDICLE SCREW(S), SPINE PLATE(S), WASHER(S) & NUT(S), Substantially Equivalent for Some Indications on 1995-08-21. Applicant: Acromed Corp..

Clearance details

Applicant: Acromed Corp.
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 1995-04-10
Decision date: 1995-08-21
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Cleveland, OH, US

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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.