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FDA 510(k)

BLACKSTONE SFS PARALLEL ROD CONNECTORS

K-Number: K080407 · 2008-03-13

ApplicantBlackstone Medical, Inc.
Decision Date2008-03-13
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BLACKSTONE SFS PARALLEL ROD CONNECTORS is the device name listed in this FDA 510(k) record. The listed applicant is Blackstone Medical, Inc.. It received FDA 510(k) clearance on 2008-03-13 under 510(k) number K080407. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLACKSTONE SFS PARALLEL ROD CONNECTORS?

BLACKSTONE SFS PARALLEL ROD CONNECTORS is a medical device that received FDA 510(k) clearance on 2008-03-13. The listed applicant is Blackstone Medical, Inc.. The 510(k) number is K080407.

When did BLACKSTONE SFS PARALLEL ROD CONNECTORS receive FDA 510(k) clearance?

BLACKSTONE SFS PARALLEL ROD CONNECTORS received FDA 510(k) clearance on 2008-03-13, under 510(k) number K080407.

Who is the listed applicant for BLACKSTONE SFS PARALLEL ROD CONNECTORS?

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

What is the FDA product code for BLACKSTONE SFS PARALLEL ROD CONNECTORS?

The FDA product code for BLACKSTONE SFS PARALLEL ROD CONNECTORS is MNI.

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Related Devices (Code: MNI)

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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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