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FDA 510(k)

Mini-OSTEO Pedicle Fixation System

K-Number: K231443 · 2023-11-21

ApplicantOsteomed Indústria E Comércio DE Implantes Ltda
Decision Date2023-11-21
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Mini-OSTEO Pedicle Fixation System is a medical device manufactured by Osteomed Indústria E Comércio DE Implantes Ltda. It received FDA 510(k) clearance on 2023-11-21 under approval number K231443. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mini-OSTEO Pedicle Fixation System?

Mini-OSTEO Pedicle Fixation System is a medical device that received FDA 510(k) clearance on 2023-11-21. It is manufactured by Osteomed Indústria E Comércio DE Implantes Ltda. The 510(k) number is K231443.

When was Mini-OSTEO Pedicle Fixation System approved by the FDA?

Mini-OSTEO Pedicle Fixation System received FDA 510(k) clearance on 2023-11-21, under approval number K231443.

What company makes Mini-OSTEO Pedicle Fixation System?

Mini-OSTEO Pedicle Fixation System is manufactured by Osteomed Indústria E Comércio DE Implantes Ltda.

What is the FDA product code for Mini-OSTEO Pedicle Fixation System?

The FDA product code for Mini-OSTEO Pedicle Fixation System is NKB.

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Related Devices (Code: NKB)

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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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