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FDA 510(k)

SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP

K-Number: K053105 · 2005-12-02

ApplicantSynthes (Usa)
Decision Date2005-12-02
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 2005-12-02 under 510(k) number K053105. 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 SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP?

SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP is a medical device that received FDA 510(k) clearance on 2005-12-02. The listed applicant is Synthes (Usa). The 510(k) number is K053105.

When did SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP receive FDA 510(k) clearance?

SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP received FDA 510(k) clearance on 2005-12-02, under 510(k) number K053105.

Who is the listed applicant for SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP?

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

What is the FDA product code for SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP?

The FDA product code for SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP is 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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