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FDA 510(k)

SBI LATERAL RADIO CAPITELLUM

K-Number: K070236 · 2007-02-21

Decision Date2007-02-21
Product CodeJDB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SBI LATERAL RADIO CAPITELLUM 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 2007-02-21 under 510(k) number K070236. 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 SBI LATERAL RADIO CAPITELLUM?

SBI LATERAL RADIO CAPITELLUM is a medical device that received FDA 510(k) clearance on 2007-02-21. The listed applicant is Small Bone Innovations, Inc.. The 510(k) number is K070236.

When did SBI LATERAL RADIO CAPITELLUM receive FDA 510(k) clearance?

SBI LATERAL RADIO CAPITELLUM received FDA 510(k) clearance on 2007-02-21, under 510(k) number K070236.

Who is the listed applicant for SBI LATERAL RADIO CAPITELLUM?

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 RADIO CAPITELLUM?

The FDA product code for SBI LATERAL RADIO CAPITELLUM is JDB.

Related Clinical Trials

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.

Other records listing Small Bone Innovations, Inc. 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.

View all 20 devices →

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.

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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