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FDA 510(k)

PANTA NAIL (DIA. 10MM), PANTA NAIL XL

K-Number: K091788 · 2009-07-29

ApplicantNewdeal Sas
Decision Date2009-07-29
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PANTA NAIL (DIA. 10MM), PANTA NAIL XL is the device name listed in this FDA 510(k) record. The listed applicant is Newdeal Sas. It received FDA 510(k) clearance on 2009-07-29 under 510(k) number K091788. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PANTA NAIL (DIA. 10MM), PANTA NAIL XL?

PANTA NAIL (DIA. 10MM), PANTA NAIL XL is a medical device that received FDA 510(k) clearance on 2009-07-29. The listed applicant is Newdeal Sas. The 510(k) number is K091788.

When did PANTA NAIL (DIA. 10MM), PANTA NAIL XL receive FDA 510(k) clearance?

PANTA NAIL (DIA. 10MM), PANTA NAIL XL received FDA 510(k) clearance on 2009-07-29, under 510(k) number K091788.

Who is the listed applicant for PANTA NAIL (DIA. 10MM), PANTA NAIL XL?

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 PANTA NAIL (DIA. 10MM), PANTA NAIL XL?

The FDA product code for PANTA NAIL (DIA. 10MM), PANTA NAIL XL is HSB.

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Other records listing Newdeal Sas as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K103623NEWDEAL INTERPHALANGEAL IMPLANTK093914NEWDEAL COMPRESSION PLATESK093781MODIFIED: NEWDEAL HALLU PLATESK083154NEWDEAL HALLU LOCK PLATE SYSTEMK091609NEWDEAL COMPRESSION PLATEK073375NEWDEAL TIBIAXYS SYSTEM

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Related Devices (Code: HSB)

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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.

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