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FDA 510(k)

ALACER SURGICAL SCAFFOLD

K-Number: K103445 · 2011-02-22

ApplicantAlacer Biomedical, Inc.
Decision Date2011-02-22
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ALACER SURGICAL SCAFFOLD is the device name listed in this FDA 510(k) record. The listed applicant is Alacer Biomedical, Inc.. It received FDA 510(k) clearance on 2011-02-22 under 510(k) number K103445. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALACER SURGICAL SCAFFOLD?

ALACER SURGICAL SCAFFOLD is a medical device that received FDA 510(k) clearance on 2011-02-22. The listed applicant is Alacer Biomedical, Inc.. The 510(k) number is K103445.

When did ALACER SURGICAL SCAFFOLD receive FDA 510(k) clearance?

ALACER SURGICAL SCAFFOLD received FDA 510(k) clearance on 2011-02-22, under 510(k) number K103445.

Who is the listed applicant for ALACER SURGICAL SCAFFOLD?

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

What is the FDA product code for ALACER SURGICAL SCAFFOLD?

The FDA product code for ALACER SURGICAL SCAFFOLD is FTL.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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