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FDA 510(k)

INJECTION PIN (KIP(02031-02061) (03031-03061))

K-Number: K221697 · 2023-03-03

ApplicantSlk Ortho, LLC
Decision Date2023-03-03
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INJECTION PIN (KIP(02031-02061) (03031-03061)) is a medical device manufactured by Slk Ortho, LLC. It received FDA 510(k) clearance on 2023-03-03 under approval number K221697. 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 INJECTION PIN (KIP(02031-02061) (03031-03061))?

INJECTION PIN (KIP(02031-02061) (03031-03061)) is a medical device that received FDA 510(k) clearance on 2023-03-03. It is manufactured by Slk Ortho, LLC. The 510(k) number is K221697.

When was INJECTION PIN (KIP(02031-02061) (03031-03061)) approved by the FDA?

INJECTION PIN (KIP(02031-02061) (03031-03061)) received FDA 510(k) clearance on 2023-03-03, under approval number K221697.

What company makes INJECTION PIN (KIP(02031-02061) (03031-03061))?

INJECTION PIN (KIP(02031-02061) (03031-03061)) is manufactured by Slk Ortho, LLC.

What is the FDA product code for INJECTION PIN (KIP(02031-02061) (03031-03061))?

The FDA product code for INJECTION PIN (KIP(02031-02061) (03031-03061)) is 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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