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FDA 510(k)

OSTEOMED NEURO RONGEUR

K-Number: K131851 · 2013-12-06

ApplicantOsteomed
Decision Date2013-12-06
Product CodeHAE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OSTEOMED NEURO RONGEUR is the device name listed in this FDA 510(k) record. The listed applicant is Osteomed. It received FDA 510(k) clearance on 2013-12-06 under 510(k) number K131851. 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 OSTEOMED NEURO RONGEUR?

OSTEOMED NEURO RONGEUR is a medical device that received FDA 510(k) clearance on 2013-12-06. The listed applicant is Osteomed. The 510(k) number is K131851.

When did OSTEOMED NEURO RONGEUR receive FDA 510(k) clearance?

OSTEOMED NEURO RONGEUR received FDA 510(k) clearance on 2013-12-06, under 510(k) number K131851.

Who is the listed applicant for OSTEOMED NEURO RONGEUR?

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

What is the FDA product code for OSTEOMED NEURO RONGEUR?

The FDA product code for OSTEOMED NEURO RONGEUR is HAE.

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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.

K260446Tontarra Punches and RongeursTontarra Medizintechnik GmbHK242759Geister 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.

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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