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FDA 510(k)

GENEROS SB SMALL BONE DISTRACTION IMPLANT

K-Number: K051162 · 2005-07-19

ApplicantOrthonetx, Inc.
Decision Date2005-07-19
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GENEROS SB SMALL BONE DISTRACTION IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Orthonetx, Inc.. It received FDA 510(k) clearance on 2005-07-19 under 510(k) number K051162. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENEROS SB SMALL BONE DISTRACTION IMPLANT?

GENEROS SB SMALL BONE DISTRACTION IMPLANT is a medical device that received FDA 510(k) clearance on 2005-07-19. The listed applicant is Orthonetx, Inc.. The 510(k) number is K051162.

When did GENEROS SB SMALL BONE DISTRACTION IMPLANT receive FDA 510(k) clearance?

GENEROS SB SMALL BONE DISTRACTION IMPLANT received FDA 510(k) clearance on 2005-07-19, under 510(k) number K051162.

Who is the listed applicant for GENEROS SB SMALL BONE DISTRACTION IMPLANT?

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

What is the FDA product code for GENEROS SB SMALL BONE DISTRACTION IMPLANT?

The FDA product code for GENEROS SB SMALL BONE DISTRACTION IMPLANT is KTT.

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Related Devices (Code: KTT)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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