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FDA 510(k)

MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK

K-Number: K033630 · 2004-04-21

ApplicantRhein 83 Srl
Decision Date2004-04-21
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK is the device name listed in this FDA 510(k) record. The listed applicant is Rhein 83 Srl. It received FDA 510(k) clearance on 2004-04-21 under 510(k) number K033630. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK?

MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK is a medical device that received FDA 510(k) clearance on 2004-04-21. The listed applicant is Rhein 83 Srl. The 510(k) number is K033630.

When did MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK receive FDA 510(k) clearance?

MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK received FDA 510(k) clearance on 2004-04-21, under 510(k) number K033630.

Who is the listed applicant for MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK?

The FDA 510(k) record lists Rhein 83 Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK?

The FDA product code for MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK is DZE.

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Other records listing Rhein 83 Srl 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: DZE)

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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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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