WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100)— 510(k) K931037

Name: FDA 510(k) clearance K931037
Creator: U.S. Food and Drug Administration
Published: 1993-07-30

Substantially Equivalent

Whitmore Ent., Inc.

FDA 510(k) clearance K931037 for WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100), Substantially Equivalent on 1993-07-30. Applicant: Whitmore Ent., Inc.. Device class: 1.

Clearance details

Applicant: Whitmore Ent., Inc.
Product code: Code FWZ
Device class: Class 1
Regulation: 21 CFR 878.4950
Advisory panel: General, Plastic Surgery
Date received: 1993-03-01
Decision date: 1993-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FWZ

product code FWZ

Malfunction: 932
Other: 1
Total: 933

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.