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FDA 510(k)

RHEAD RADIAL HEAD EXTENDED STEMS

K-Number: K102180 · 2010-12-20

ApplicantSmall Bone Innovations, Inc.
Decision Date2010-12-20
Product CodeJDB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RHEAD RADIAL HEAD EXTENDED STEMS is the device name listed in this FDA 510(k) record. The listed applicant is Small Bone Innovations, Inc.. It received FDA 510(k) clearance on 2010-12-20 under 510(k) number K102180. 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 RHEAD RADIAL HEAD EXTENDED STEMS?

RHEAD RADIAL HEAD EXTENDED STEMS is a medical device that received FDA 510(k) clearance on 2010-12-20. The listed applicant is Small Bone Innovations, Inc.. The 510(k) number is K102180.

When did RHEAD RADIAL HEAD EXTENDED STEMS receive FDA 510(k) clearance?

RHEAD RADIAL HEAD EXTENDED STEMS received FDA 510(k) clearance on 2010-12-20, under 510(k) number K102180.

Who is the listed applicant for RHEAD RADIAL HEAD EXTENDED STEMS?

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

What is the FDA product code for RHEAD RADIAL HEAD EXTENDED STEMS?

The FDA product code for RHEAD RADIAL HEAD EXTENDED STEMS is JDB.

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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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