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FDA 510(k)

BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM

K-Number: K093321 · 2010-04-02

ApplicantBioHorizons Implant Systems, Inc.
Decision Date2010-04-02
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM 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 2010-04-02 under 510(k) number K093321. 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 LASER-LOK 3.0 IMPLANT SYSTEM?

BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2010-04-02. The listed applicant is BioHorizons Implant Systems, Inc.. The 510(k) number is K093321.

When did BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM receive FDA 510(k) clearance?

BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM received FDA 510(k) clearance on 2010-04-02, under 510(k) number K093321.

Who is the listed applicant for BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM?

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 LASER-LOK 3.0 IMPLANT SYSTEM?

The FDA product code for BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM is DZE.

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Other records listing BioHorizons Implant Systems, Inc. as applicant

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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.

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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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