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FDA 510(k)

BioHorizons Tapered Short Implants

K-Number: K172576 · 2017-11-22

Decision Date2017-11-22
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BioHorizons Tapered Short Implants is the device name listed in this FDA 510(k) record. The listed applicant is BioHorizons Implant Systems, Inc.. It received FDA 510(k) clearance on 2017-11-22 under 510(k) number K172576. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioHorizons Tapered Short Implants?

BioHorizons Tapered Short Implants is a medical device that received FDA 510(k) clearance on 2017-11-22. The listed applicant is BioHorizons Implant Systems, Inc.. The 510(k) number is K172576.

When did BioHorizons Tapered Short Implants receive FDA 510(k) clearance?

BioHorizons Tapered Short Implants received FDA 510(k) clearance on 2017-11-22, under 510(k) number K172576.

Who is the listed applicant for BioHorizons Tapered Short Implants?

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

What is the FDA product code for BioHorizons Tapered Short Implants?

The FDA product code for BioHorizons Tapered Short Implants is DZE.

Other records listing BioHorizons Implant Systems, 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 10 devices →

Related Devices (Code: DZE)

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

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