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)

Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs

K-Number: K150468 · 2016-02-29

ApplicantK2 Medical GmbH & Co. KG
Decision Date2016-02-29
Product CodeHAE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs is the device name listed in this FDA 510(k) record. The listed applicant is K2 Medical GmbH & Co. KG. It received FDA 510(k) clearance on 2016-02-29 under 510(k) number K150468. The device is classified under product code HAE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs?

Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs is a medical device that received FDA 510(k) clearance on 2016-02-29. The listed applicant is K2 Medical GmbH & Co. KG. The 510(k) number is K150468.

When did Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs receive FDA 510(k) clearance?

Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs received FDA 510(k) clearance on 2016-02-29, under 510(k) number K150468.

Who is the listed applicant for Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs?

The FDA 510(k) record lists K2 Medical GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs?

The FDA product code for Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs is HAE.

Related Devices (Code: HAE)

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.

K242759Geister K-Rex rongeursGeister Medizin Technik GmbHK223596SQ.line KERRISONAesculap, Inc.K230256Rebellion, Phantom Multi-Bite Kerrison RongeurMorpheus AGK221818Rebellion; Phantom Multi-Bite Kerrison RongeurMorpheus AGK210741KLS Martin Neuro RongeursKLS-Martin L.P.K200768Rebellion, Phantom Multi-Bite Kerrison RongeurMorpheus AG

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.

↑