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FDA 510(k)

OSTEOPHIL BETA-TCP

K-Number: K102937 · 2010-12-27

ApplicantCytophil, Inc.
Decision Date2010-12-27
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEOPHIL BETA-TCP is the device name listed in this FDA 510(k) record. The listed applicant is Cytophil, Inc.. It received FDA 510(k) clearance on 2010-12-27 under 510(k) number K102937. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTEOPHIL BETA-TCP?

OSTEOPHIL BETA-TCP is a medical device that received FDA 510(k) clearance on 2010-12-27. The listed applicant is Cytophil, Inc.. The 510(k) number is K102937.

When did OSTEOPHIL BETA-TCP receive FDA 510(k) clearance?

OSTEOPHIL BETA-TCP received FDA 510(k) clearance on 2010-12-27, under 510(k) number K102937.

Who is the listed applicant for OSTEOPHIL BETA-TCP?

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

What is the FDA product code for OSTEOPHIL BETA-TCP?

The FDA product code for OSTEOPHIL BETA-TCP is MQV.

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Other records listing Cytophil, Inc. 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.

K121795CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANTK093871PERIOPHIL B-TCPK092788PERIOPHIL BIPHASICK081815VOCALIS GELK081816VOCALIS AND VOCALIS SMK072219CYTOPHIL TISSUE MARKER

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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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