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FDA 510(k)

OCTAVE SPEEDER SPINE

K-Number: K121911 · 2012-08-17

ApplicantToshiba Medical Systems Corporation, Japan
Decision Date2012-08-17
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OCTAVE SPEEDER SPINE is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba Medical Systems Corporation, Japan. It received FDA 510(k) clearance on 2012-08-17 under 510(k) number K121911. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCTAVE SPEEDER SPINE?

OCTAVE SPEEDER SPINE is a medical device that received FDA 510(k) clearance on 2012-08-17. The listed applicant is Toshiba Medical Systems Corporation, Japan. The 510(k) number is K121911.

When did OCTAVE SPEEDER SPINE receive FDA 510(k) clearance?

OCTAVE SPEEDER SPINE received FDA 510(k) clearance on 2012-08-17, under 510(k) number K121911.

Who is the listed applicant for OCTAVE SPEEDER SPINE?

The FDA 510(k) record lists Toshiba Medical Systems Corporation, Japan as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OCTAVE SPEEDER SPINE?

The FDA product code for OCTAVE SPEEDER SPINE is MOS.

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Other records listing Toshiba Medical Systems Corporation, Japan 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.

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Related Devices (Code: MOS)

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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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