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FDA 510(k)

Dry DBM- A Putty

K-Number: K212135 · 2021-10-04

ApplicantSeaspine Corporation
Decision Date2021-10-04
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Dry DBM- A Putty is the device name listed in this FDA 510(k) record. The listed applicant is Seaspine Corporation. It received FDA 510(k) clearance on 2021-10-04 under 510(k) number K212135. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dry DBM- A Putty?

Dry DBM- A Putty is a medical device that received FDA 510(k) clearance on 2021-10-04. The listed applicant is Seaspine Corporation. The 510(k) number is K212135.

When did Dry DBM- A Putty receive FDA 510(k) clearance?

Dry DBM- A Putty received FDA 510(k) clearance on 2021-10-04, under 510(k) number K212135.

Who is the listed applicant for Dry DBM- A Putty?

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

What is the FDA product code for Dry DBM- A Putty?

The FDA product code for Dry DBM- A Putty is MQV.

Other records listing Seaspine Corporation 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.

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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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