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FDA 510(k)

BONE BLOCK FIXATION SET

K-Number: K050515 · 2005-04-05

ApplicantStraumann USA, Inc.
Decision Date2005-04-05
Product CodeDZL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BONE BLOCK FIXATION SET is the device name listed in this FDA 510(k) record. The listed applicant is Straumann USA, Inc.. It received FDA 510(k) clearance on 2005-04-05 under 510(k) number K050515. The device is classified under product code DZL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONE BLOCK FIXATION SET?

BONE BLOCK FIXATION SET is a medical device that received FDA 510(k) clearance on 2005-04-05. The listed applicant is Straumann USA, Inc.. The 510(k) number is K050515.

When did BONE BLOCK FIXATION SET receive FDA 510(k) clearance?

BONE BLOCK FIXATION SET received FDA 510(k) clearance on 2005-04-05, under 510(k) number K050515.

Who is the listed applicant for BONE BLOCK FIXATION SET?

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

What is the FDA product code for BONE BLOCK FIXATION SET?

The FDA product code for BONE BLOCK FIXATION SET is DZL.

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Related Devices (Code: DZL)

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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