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FDA 510(k)

CINCH BONE ANCHOR SYSTEM

K-Number: K062739 · 2007-02-13

ApplicantSapphire Medical, Inc.
Decision Date2007-02-13
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CINCH BONE ANCHOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sapphire Medical, Inc.. It received FDA 510(k) clearance on 2007-02-13 under 510(k) number K062739. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CINCH BONE ANCHOR SYSTEM?

CINCH BONE ANCHOR SYSTEM is a medical device that received FDA 510(k) clearance on 2007-02-13. The listed applicant is Sapphire Medical, Inc.. The 510(k) number is K062739.

When did CINCH BONE ANCHOR SYSTEM receive FDA 510(k) clearance?

CINCH BONE ANCHOR SYSTEM received FDA 510(k) clearance on 2007-02-13, under 510(k) number K062739.

Who is the listed applicant for CINCH BONE ANCHOR SYSTEM?

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

What is the FDA product code for CINCH BONE ANCHOR SYSTEM?

The FDA product code for CINCH BONE ANCHOR SYSTEM is MBI.

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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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