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FDA 510(k)

2.5MM INLINE FUSION PLATE

K-Number: K131867 · 2013-10-29

ApplicantBiomet, Inc.
Decision Date2013-10-29
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

2.5MM INLINE FUSION PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2013-10-29 under 510(k) number K131867. 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 2.5MM INLINE FUSION PLATE?

2.5MM INLINE FUSION PLATE is a medical device that received FDA 510(k) clearance on 2013-10-29. The listed applicant is Biomet, Inc.. The 510(k) number is K131867.

When did 2.5MM INLINE FUSION PLATE receive FDA 510(k) clearance?

2.5MM INLINE FUSION PLATE received FDA 510(k) clearance on 2013-10-29, under 510(k) number K131867.

Who is the listed applicant for 2.5MM INLINE FUSION PLATE?

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 2.5MM INLINE FUSION PLATE?

The FDA product code for 2.5MM INLINE FUSION PLATE is HRS.

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Related Devices (Code: HRS)

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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