FDA 510(k)

NEWDEAL INTERPHALANGEAL IMPLANT

K-Number: K103623 · 2012-03-20

Decision Date2012-03-20

Product CodeHTY

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

NEWDEAL INTERPHALANGEAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Newdeal Sas. It received FDA 510(k) clearance on 2012-03-20 under 510(k) number K103623. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEWDEAL INTERPHALANGEAL IMPLANT?

NEWDEAL INTERPHALANGEAL IMPLANT is a medical device that received FDA 510(k) clearance on 2012-03-20. The listed applicant is Newdeal Sas. The 510(k) number is K103623.

When did NEWDEAL INTERPHALANGEAL IMPLANT receive FDA 510(k) clearance?

NEWDEAL INTERPHALANGEAL IMPLANT received FDA 510(k) clearance on 2012-03-20, under 510(k) number K103623.

Who is the listed applicant for NEWDEAL INTERPHALANGEAL IMPLANT?

The FDA 510(k) record lists Newdeal Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEWDEAL INTERPHALANGEAL IMPLANT?

The FDA product code for NEWDEAL INTERPHALANGEAL IMPLANT is HTY.

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Other records listing Newdeal Sas as applicant

K093914NEWDEAL COMPRESSION PLATES K093781MODIFIED: NEWDEAL HALLU PLATES K091788PANTA NAIL (DIA. 10MM), PANTA NAIL XL K083154NEWDEAL HALLU LOCK PLATE SYSTEM K091609NEWDEAL COMPRESSION PLATE K073375NEWDEAL TIBIAXYS SYSTEM

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.