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FDA 510(k)

SBI LATERAL RHEAD IMPLANT

K-Number: K062898 · 2006-11-13

ApplicantSmall Bone Innovations, Inc.
Decision Date2006-11-13
Product CodeKWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SBI LATERAL RHEAD IMPLANT 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 2006-11-13 under 510(k) number K062898. The device is classified under product code KWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SBI LATERAL RHEAD IMPLANT?

SBI LATERAL RHEAD IMPLANT is a medical device that received FDA 510(k) clearance on 2006-11-13. The listed applicant is Small Bone Innovations, Inc.. The 510(k) number is K062898.

When did SBI LATERAL RHEAD IMPLANT receive FDA 510(k) clearance?

SBI LATERAL RHEAD IMPLANT received FDA 510(k) clearance on 2006-11-13, under 510(k) number K062898.

Who is the listed applicant for SBI LATERAL RHEAD IMPLANT?

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 SBI LATERAL RHEAD IMPLANT?

The FDA product code for SBI LATERAL RHEAD IMPLANT is KWI.

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Other records listing Small Bone Innovations, Inc. as applicant

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Related Devices (Code: KWI)

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.

K260624Arthrex Radial Head Replacement SystemArthrex, Inc.K233592BioPoly Radial Head ImplantBioPoly, LLCK231188ALIGN Radial Head SystemSkeletal Dynamics, Inc.K213563DePuy Synthes Radial Head Replacement SystemDePuy SynthesK212872Avenger Radial Head SystemIn2bones USA, LLCK192754Avenger Radial Head SystemIn2bones USA, LLC

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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