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FDA 510(k)

12MM AND 13MM TIBIAL NAILS

K-Number: K130625 · 2013-03-28

ApplicantAdvanced Orthopaedic Solutions, Inc.
Decision Date2013-03-28
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

12MM AND 13MM TIBIAL NAILS is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Orthopaedic Solutions, Inc.. It received FDA 510(k) clearance on 2013-03-28 under 510(k) number K130625. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 12MM AND 13MM TIBIAL NAILS?

12MM AND 13MM TIBIAL NAILS is a medical device that received FDA 510(k) clearance on 2013-03-28. The listed applicant is Advanced Orthopaedic Solutions, Inc.. The 510(k) number is K130625.

When did 12MM AND 13MM TIBIAL NAILS receive FDA 510(k) clearance?

12MM AND 13MM TIBIAL NAILS received FDA 510(k) clearance on 2013-03-28, under 510(k) number K130625.

Who is the listed applicant for 12MM AND 13MM TIBIAL NAILS?

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

What is the FDA product code for 12MM AND 13MM TIBIAL NAILS?

The FDA product code for 12MM AND 13MM TIBIAL NAILS is HSB.

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Other records listing Advanced Orthopaedic Solutions, Inc. as applicant

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K202489AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating SystemK202099AOS Galileo™ Trochanteric Nail SystemK191598AOS ES Retrograde Femoral NailK160409AOS Anterolateral Proximal Humeral PlateK133081TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEGRADE FEMORAL NAILS, RETROGRADE FEMORAL NK132005RETROGRADE FEMORAL NAIL

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Related Devices (Code: HSB)

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.

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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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