DAY STAPLE— 510(k) K853267

Substantially Equivalent for Some Indications

Protek, Inc.

FDA 510(k) clearance K853267 for DAY STAPLE, Substantially Equivalent for Some Indications on 1985-09-06. Applicant: Protek, Inc..

Clearance details

Applicant: Protek, Inc.
Product code: Code JDR
Advisory panel: Orthopedic
Date received: 1985-08-05
Decision date: 1985-09-06
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Indianapolis, IN, US

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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.