OSTEORAPTOR SUTURE ANCHOR— 510(k) K082215

Substantially Equivalent

Smith & Nephew Inc., Endoscopy Division

FDA 510(k) clearance K082215 for OSTEORAPTOR SUTURE ANCHOR, Substantially Equivalent on 2008-11-03. Applicant: Smith & Nephew Inc., Endoscopy Division.

Clearance details

Applicant: Smith & Nephew Inc., Endoscopy Division
Product code: Code JDR
Advisory panel: Orthopedic
Date received: 2008-08-06
Decision date: 2008-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

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.