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FDA 510(k)

SYNTHASOME X-REPAIR

K-Number: K083307 · 2009-03-27

ApplicantSynthasome, Inc.
Decision Date2009-03-27
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SYNTHASOME X-REPAIR is the device name listed in this FDA 510(k) record. The listed applicant is Synthasome, Inc.. It received FDA 510(k) clearance on 2009-03-27 under 510(k) number K083307. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHASOME X-REPAIR?

SYNTHASOME X-REPAIR is a medical device that received FDA 510(k) clearance on 2009-03-27. The listed applicant is Synthasome, Inc.. The 510(k) number is K083307.

When did SYNTHASOME X-REPAIR receive FDA 510(k) clearance?

SYNTHASOME X-REPAIR received FDA 510(k) clearance on 2009-03-27, under 510(k) number K083307.

Who is the listed applicant for SYNTHASOME X-REPAIR?

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

What is the FDA product code for SYNTHASOME X-REPAIR?

The FDA product code for SYNTHASOME X-REPAIR is FTL.

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Related Devices (Code: FTL)

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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.

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