PANALOK ABSORBABLE SUTURE ANCHOR SYSTEM— 510(k) K950272

Substantially Equivalent for Some Indications

ETHICON, Inc.

FDA 510(k) clearance K950272 for PANALOK ABSORBABLE SUTURE ANCHOR SYSTEM, Substantially Equivalent for Some Indications on 1996-01-18. Applicant: ETHICON, Inc..

Clearance details

Applicant: ETHICON, Inc.
Product code: Code JDR
Advisory panel: Orthopedic
Date received: 1995-01-23
Decision date: 1996-01-18
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Somerville, NJ, 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.