Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Slk Ortho, LLC. It received FDA 510(k) clearance on 2023-03-03 under 510(k) 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. The listed applicant is Slk Ortho, LLC. The 510(k) number is K221697.

When did INJECTION PIN (KIP(02031-02061) (03031-03061)) receive FDA 510(k) clearance?

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

Who is the listed applicant for INJECTION PIN (KIP(02031-02061) (03031-03061))?

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

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.

Related Devices (Code: NDN)

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.

K251896XeliteMed SuperM-Fix Spinal Bone CementXelite Biomed , Ltd.K250637VCFix Spinal SystemAmber ImplantsK243537XeliteMed VertehighFix High Viscosity Spinal Bone Cement SystemXelite Biomed , Ltd.K241775XeliteMed VertehighFix High Viscosity Spinal Bone CementXelite Biomed , Ltd.K232842Balloon Inflation SystemNingbo Hicren Biotechnology Co., Ltd.K240084V-STRUT® Vertebral ImplantHyprevention

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.

↑