NEWDEAL COMPRESSION PLATE— 510(k) K070447

Name: FDA 510(k) clearance K070447
Creator: U.S. Food and Drug Administration
Published: 2007-03-29

Substantially Equivalent

Newdeal Sas

FDA 510(k) clearance K070447 for NEWDEAL COMPRESSION PLATE, Substantially Equivalent on 2007-03-29. Applicant: Newdeal Sas. Device class: 2.

Clearance details

Applicant: Newdeal Sas
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2007-02-15
Decision date: 2007-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Planisboro, NJ, US

Download summary PDF View on FDA.gov ↗

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K261511 — Xpert Ankle2026-07-28

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K103623 — NEWDEAL INTERPHALANGEAL IMPLANT2012-03-20
K093914 — NEWDEAL COMPRESSION PLATES2011-04-14
K093781 — MODIFIED: NEWDEAL HALLU PLATES2010-01-22
K091788 — PANTA NAIL (DIA. 10MM), PANTA NAIL XL2009-07-29
K083154 — NEWDEAL HALLU LOCK PLATE SYSTEM2009-07-10

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.