MITEK PDS/PGA STAPLE— 510(k) K021953

Name: FDA 510(k) clearance K021953
Creator: U.S. Food and Drug Administration
Published: 2002-12-20

Substantially Equivalent

Mitek Worldwide

FDA 510(k) clearance K021953 for MITEK PDS/PGA STAPLE, Substantially Equivalent on 2002-12-20. Applicant: Mitek Worldwide. Device class: 2.

Clearance details

Applicant: Mitek Worldwide
Product code: Code JDR
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2002-06-13
Decision date: 2002-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwood, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JDR

view all

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

More clearances from Mitek Worldwide

view all

K032717 — BIOCRYL RAPIDE INTERFERENCE SCREW2004-03-31
K032167 — BIO-INTRAFIX TIBIAL SCREW AND SHEATH2003-10-15
K032078 — MITEK MICRO QUICKANCHOR2003-08-25
K030995 — MINILOK QUICKANCHOR PLUS2003-06-26
K031519 — CUFFLOK ANCHOR2003-06-06

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.