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FDA 510(k)

Avenue P Cage System

K-Number: K181096 · 2019-01-15

Decision Date2019-01-15
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Avenue P Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Biomet Spine, Inc.. It received FDA 510(k) clearance on 2019-01-15 under 510(k) number K181096. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Avenue P Cage System?

Avenue P Cage System is a medical device that received FDA 510(k) clearance on 2019-01-15. The listed applicant is Zimmer Biomet Spine, Inc.. The 510(k) number is K181096.

When did Avenue P Cage System receive FDA 510(k) clearance?

Avenue P Cage System received FDA 510(k) clearance on 2019-01-15, under 510(k) number K181096.

Who is the listed applicant for Avenue P Cage System?

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

What is the FDA product code for Avenue P Cage System?

The FDA product code for Avenue P Cage System is OVD.

Other records listing Zimmer Biomet Spine, Inc. as applicant

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.

View all 15 devices →

Related Devices (Code: OVD)

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.

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.