XANCHOR SUTURE ATTACHMENT DEVICE— 510(k) K932041

Name: FDA 510(k) clearance K932041
Creator: U.S. Food and Drug Administration
Published: 1994-08-12

Substantially Equivalent for Some Indications

Orthopaedic Biosystems

FDA 510(k) clearance K932041 for XANCHOR SUTURE ATTACHMENT DEVICE, Substantially Equivalent for Some Indications on 1994-08-12. Applicant: Orthopaedic Biosystems. Device class: 2.

Clearance details

Applicant: Orthopaedic Biosystems
Product code: Code JDR
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 1993-04-27
Decision date: 1994-08-12
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Mesa, AZ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JDR

product code JDR

Injury: 726
Malfunction: 663
Other: 1
Total: 1,390

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.