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FDA 510(k)

SBI ULNAR HEAD IMPLANT

K-Number: K061146 · 2006-07-19

ApplicantSmall Bone Innovations, Inc.
Decision Date2006-07-19
Product CodeKXE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SBI ULNAR HEAD 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 2006-07-19 under 510(k) number K061146. The device is classified under product code KXE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SBI ULNAR HEAD IMPLANT?

SBI ULNAR HEAD IMPLANT is a medical device that received FDA 510(k) clearance on 2006-07-19. The listed applicant is Small Bone Innovations, Inc.. The 510(k) number is K061146.

When did SBI ULNAR HEAD IMPLANT receive FDA 510(k) clearance?

SBI ULNAR HEAD IMPLANT received FDA 510(k) clearance on 2006-07-19, under 510(k) number K061146.

Who is the listed applicant for SBI ULNAR HEAD 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 ULNAR HEAD IMPLANT?

The FDA product code for SBI ULNAR HEAD IMPLANT is KXE.

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Other records listing Small Bone Innovations, Inc. as applicant

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Related Devices (Code: KXE)

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.

K190599Aptis Medical Distal Radio Ulnar Joint ImplantAptis Medical, LLCK112481FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANTAscension OrthopedicK081025ISOELASTICURemi Sciences, Inc.K082839DISTAL RADIO-ULNAR JOINT IMPLANTAptis Medical, LLCK053119DISTAL RADIO-ULNAR JOINT IMPLANTAptis Medical, LLCK052137ASCENSION MUHAscension Orthopedics, Inc.

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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