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FDA 510(k)

RHS

K-Number: K060438 · 2006-04-18

ApplicantTornier
Decision Date2006-04-18
Product CodeJDB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RHS is the device name listed in this FDA 510(k) record. The listed applicant is Tornier. It received FDA 510(k) clearance on 2006-04-18 under 510(k) number K060438. The device is classified under product code JDB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RHS?

RHS is a medical device that received FDA 510(k) clearance on 2006-04-18. The listed applicant is Tornier. The 510(k) number is K060438.

When did RHS receive FDA 510(k) clearance?

RHS received FDA 510(k) clearance on 2006-04-18, under 510(k) number K060438.

Who is the listed applicant for RHS?

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

What is the FDA product code for RHS?

The FDA product code for RHS is JDB.

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Related Devices (Code: JDB)

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

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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