COLLAGEN TENDON SHEET— 510(k) K112423

Name: FDA 510(k) clearance K112423
Creator: U.S. Food and Drug Administration
Published: 2011-12-22

Substantially Equivalent

Rotation Medical, Inc.

FDA 510(k) clearance K112423 for COLLAGEN TENDON SHEET, Substantially Equivalent on 2011-12-22. Applicant: Rotation Medical, Inc.. Device class: 2.

Clearance details

Applicant: Rotation Medical, Inc.
Product code: Code FTM
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2011-08-23
Decision date: 2011-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Rotation Medical, Inc.

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K140300 — COLLAGEN TENDON SHEET-DDI (CTS-DDI)2014-03-26
K131635 — ROTATION MEDICAL BONE STAPLE (RMB STAPLE)2013-08-29
K131637 — ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE)2013-07-12
K122048 — COLLAGEN TENDON SHEET-D2013-01-08

Adverse events under product code FTM

product code FTM

Death: 17
Injury: 2,174
Total: 2,191

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.