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FDA 510(k)

SURGYBONE

K-Number: K083569 · 2009-04-01

ApplicantSilfradent S.R.L.
Decision Date2009-04-01
Product CodeDZI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SURGYBONE is the device name listed in this FDA 510(k) record. The listed applicant is Silfradent S.R.L.. It received FDA 510(k) clearance on 2009-04-01 under 510(k) number K083569. The device is classified under product code DZI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGYBONE?

SURGYBONE is a medical device that received FDA 510(k) clearance on 2009-04-01. The listed applicant is Silfradent S.R.L.. The 510(k) number is K083569.

When did SURGYBONE receive FDA 510(k) clearance?

SURGYBONE received FDA 510(k) clearance on 2009-04-01, under 510(k) number K083569.

Who is the listed applicant for SURGYBONE?

The FDA 510(k) record lists Silfradent S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGYBONE?

The FDA product code for SURGYBONE is DZI.

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Related Devices (Code: DZI)

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.

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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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