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FDA 510(k)

VERTECEM II CEMENT KIT

K-Number: K121876 · 2012-10-19

ApplicantAap Biomaterials GmbH
Decision Date2012-10-19
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VERTECEM II CEMENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Aap Biomaterials GmbH. It received FDA 510(k) clearance on 2012-10-19 under 510(k) number K121876. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERTECEM II CEMENT KIT?

VERTECEM II CEMENT KIT is a medical device that received FDA 510(k) clearance on 2012-10-19. The listed applicant is Aap Biomaterials GmbH. The 510(k) number is K121876.

When did VERTECEM II CEMENT KIT receive FDA 510(k) clearance?

VERTECEM II CEMENT KIT received FDA 510(k) clearance on 2012-10-19, under 510(k) number K121876.

Who is the listed applicant for VERTECEM II CEMENT KIT?

The FDA 510(k) record lists Aap Biomaterials GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VERTECEM II CEMENT KIT?

The FDA product code for VERTECEM II CEMENT KIT is NDN.

Related Clinical Trials

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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Other records listing Aap Biomaterials GmbH 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.

K090460BONOS INJECT

Related Devices (Code: NDN)

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

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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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