TENSTAPLE ORTHOPEDIC STAPLING SYSTEM— 510(k) K896471

Name: FDA 510(k) clearance K896471
Creator: U.S. Food and Drug Administration
Published: 1990-07-24

Substantially Equivalent

Tenstaple, Inc.

FDA 510(k) clearance K896471 for TENSTAPLE ORTHOPEDIC STAPLING SYSTEM, Substantially Equivalent on 1990-07-24. Applicant: Tenstaple, Inc.. Device class: 2.

Clearance details

Applicant: Tenstaple, Inc.
Product code: Code JDR
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 1989-11-13
Decision date: 1990-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melvern, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JDR

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K262451 — Arthrex DynaNite Staples2026-09-01
K261121 — Megalodon Dynamic Compression System2026-08-06
K250712 — Linkt Compression Staple System2025-05-14
K243888 — Medline UNITE® REFLEX® Hybrid Nitinol Implant System2025-04-11
K243742 — Arthrex DynaNite Nitinol Staples2025-01-31

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.