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FDA 510(k)

CORTOSS BONE AUGMENTATION MATERIAL

K-Number: K080108 · 2009-06-05

ApplicantOrthovita, Inc.
Decision Date2009-06-05
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CORTOSS BONE AUGMENTATION MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Orthovita, Inc.. It received FDA 510(k) clearance on 2009-06-05 under 510(k) number K080108. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORTOSS BONE AUGMENTATION MATERIAL?

CORTOSS BONE AUGMENTATION MATERIAL is a medical device that received FDA 510(k) clearance on 2009-06-05. The listed applicant is Orthovita, Inc.. The 510(k) number is K080108.

When did CORTOSS BONE AUGMENTATION MATERIAL receive FDA 510(k) clearance?

CORTOSS BONE AUGMENTATION MATERIAL received FDA 510(k) clearance on 2009-06-05, under 510(k) number K080108.

Who is the listed applicant for CORTOSS BONE AUGMENTATION MATERIAL?

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

What is the FDA product code for CORTOSS BONE AUGMENTATION MATERIAL?

The FDA product code for CORTOSS BONE AUGMENTATION MATERIAL is NDN.

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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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