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FDA 510(k)

KLS Martin Neuro Rongeurs

K-Number: K210741 · 2022-06-03

ApplicantKLS-Martin L.P.
Decision Date2022-06-03
Product CodeHAE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

KLS Martin Neuro Rongeurs is the device name listed in this FDA 510(k) record. The listed applicant is KLS-Martin L.P.. It received FDA 510(k) clearance on 2022-06-03 under 510(k) number K210741. 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 KLS Martin Neuro Rongeurs?

KLS Martin Neuro Rongeurs is a medical device that received FDA 510(k) clearance on 2022-06-03. The listed applicant is KLS-Martin L.P.. The 510(k) number is K210741.

When did KLS Martin Neuro Rongeurs receive FDA 510(k) clearance?

KLS Martin Neuro Rongeurs received FDA 510(k) clearance on 2022-06-03, under 510(k) number K210741.

Who is the listed applicant for KLS Martin Neuro Rongeurs?

The FDA 510(k) record lists KLS-Martin L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KLS Martin Neuro Rongeurs?

The FDA product code for KLS Martin Neuro Rongeurs is HAE.

Other records listing KLS-Martin L.P. as applicant

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.

K254162KLS Martin Ixos SystemK253660KLS Martin Pure Pectus SystemK250988KLS Martin Pure Pectus SystemK250865KLS Martin IPS Forearm SystemK252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILEK250620KLS Martin Ixos System

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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 AGK200768Rebellion, Phantom Multi-Bite Kerrison RongeurMorpheus AGK200387Ace Medical Surgical InstrumentsAce Medical

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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