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FDA 510(k)

K2M Patient Specific Rods

K-Number: K180376 · 2018-04-05

ApplicantK2m, Inc.
Decision Date2018-04-05
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

K2M Patient Specific Rods is a medical device manufactured by K2m, Inc.. It received FDA 510(k) clearance on 2018-04-05 under approval number K180376. 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 K2M Patient Specific Rods?

K2M Patient Specific Rods is a medical device that received FDA 510(k) clearance on 2018-04-05. It is manufactured by K2m, Inc.. The 510(k) number is K180376.

When was K2M Patient Specific Rods approved by the FDA?

K2M Patient Specific Rods received FDA 510(k) clearance on 2018-04-05, under approval number K180376.

What company makes K2M Patient Specific Rods?

K2M Patient Specific Rods is manufactured by K2m, Inc..

What is the FDA product code for K2M Patient Specific Rods?

The FDA product code for K2M Patient Specific Rods is NKB.

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Related PubMed Literature

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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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