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FDA 510(k)

SPIDER SYSTEM KOLIBRI CEMENT NEEDLE

K-Number: K130402 · 2013-04-01

ApplicantSintea Plustek, LLC
Decision Date2013-04-01
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPIDER SYSTEM KOLIBRI CEMENT NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Sintea Plustek, LLC. It received FDA 510(k) clearance on 2013-04-01 under 510(k) number K130402. 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 SPIDER SYSTEM KOLIBRI CEMENT NEEDLE?

SPIDER SYSTEM KOLIBRI CEMENT NEEDLE is a medical device that received FDA 510(k) clearance on 2013-04-01. The listed applicant is Sintea Plustek, LLC. The 510(k) number is K130402.

When did SPIDER SYSTEM KOLIBRI CEMENT NEEDLE receive FDA 510(k) clearance?

SPIDER SYSTEM KOLIBRI CEMENT NEEDLE received FDA 510(k) clearance on 2013-04-01, under 510(k) number K130402.

Who is the listed applicant for SPIDER SYSTEM KOLIBRI CEMENT NEEDLE?

The FDA 510(k) record lists Sintea Plustek, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPIDER SYSTEM KOLIBRI CEMENT NEEDLE?

The FDA product code for SPIDER SYSTEM KOLIBRI CEMENT NEEDLE is NDN.

Related Clinical Trials

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Other records listing Sintea Plustek, LLC 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.

K112861SINTEA PLUSTEK ANTERIOR CERVICAL PLATE SYSTEM

Related Devices (Code: NDN)

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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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