Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )— 510(k) K230036

Name: FDA 510(k) clearance K230036
Creator: U.S. Food and Drug Administration
Published: 2023-06-23

Substantially Equivalent

Rti Surgical, Inc.

FDA 510(k) clearance K230036 for Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ), Substantially Equivalent on 2023-06-23. Applicant: Rti Surgical, Inc.. Device class: 2.

Clearance details

Applicant: Rti Surgical, Inc.
Product code: Code GAT
Device class: Class 2
Regulation: 21 CFR 878.5000
Advisory panel: General, Plastic Surgery
Date received: 2022-12-27
Decision date: 2023-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alachua, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GAT

product code GAT

Death: 19
Injury: 4,163
Malfunction: 8,646
Other: 2
Total: 12,830

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.