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FDA 510(k)

SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL

K-Number: K123745 · 2013-03-25

ApplicantBiomecanica Industria E Comerico DE Productos Orto
Decision Date2013-03-25
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL is the device name listed in this FDA 510(k) record. The listed applicant is Biomecanica Industria E Comerico DE Productos Orto. It received FDA 510(k) clearance on 2013-03-25 under 510(k) number K123745. 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 SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL?

SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL is a medical device that received FDA 510(k) clearance on 2013-03-25. The listed applicant is Biomecanica Industria E Comerico DE Productos Orto. The 510(k) number is K123745.

When did SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL receive FDA 510(k) clearance?

SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL received FDA 510(k) clearance on 2013-03-25, under 510(k) number K123745.

Who is the listed applicant for SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL?

The FDA 510(k) record lists Biomecanica Industria E Comerico DE Productos Orto as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL?

The FDA product code for SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL is HSB.

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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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