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FDA 510(k)

LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT)

K-Number: K131670 · 2013-07-03

ApplicantBiomet, Inc.
Decision Date2013-07-03
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT) is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2013-07-03 under 510(k) number K131670. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT)?

LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT) is a medical device that received FDA 510(k) clearance on 2013-07-03. The listed applicant is Biomet, Inc.. The 510(k) number is K131670.

When did LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT) receive FDA 510(k) clearance?

LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT) received FDA 510(k) clearance on 2013-07-03, under 510(k) number K131670.

Who is the listed applicant for LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT)?

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

What is the FDA product code for LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT)?

The FDA product code for LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT) is HRS.

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Related Devices (Code: HRS)

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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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