FDA 510(k)

BOND BONE

K-Number: K083858 · 2009-03-17

Decision Date2009-03-17

Product CodeLYC

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

BOND BONE is the device name listed in this FDA 510(k) record. The listed applicant is Augma Biomaterials, Ltd.. It received FDA 510(k) clearance on 2009-03-17 under 510(k) number K083858. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOND BONE?

BOND BONE is a medical device that received FDA 510(k) clearance on 2009-03-17. The listed applicant is Augma Biomaterials, Ltd.. The 510(k) number is K083858.

When did BOND BONE receive FDA 510(k) clearance?

BOND BONE received FDA 510(k) clearance on 2009-03-17, under 510(k) number K083858.

Who is the listed applicant for BOND BONE?

The FDA 510(k) record lists Augma Biomaterials, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BOND BONE?

The FDA product code for BOND BONE is LYC.

Other records listing Augma Biomaterials, Ltd. 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.

K121177BOND APATITE

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Official Source

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