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FDA 510(k)

CEMENT AND BONE REMOVAL KIT

K-Number: K961759 · 1996-06-13

ApplicantMaillefer Instruments S.A.
Decision Date1996-06-13
Product CodeHWE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CEMENT AND BONE REMOVAL KIT is the device name listed in this FDA 510(k) record. The listed applicant is Maillefer Instruments S.A.. It received FDA 510(k) clearance on 1996-06-13 under 510(k) number K961759. The device is classified under product code HWE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEMENT AND BONE REMOVAL KIT?

CEMENT AND BONE REMOVAL KIT is a medical device that received FDA 510(k) clearance on 1996-06-13. The listed applicant is Maillefer Instruments S.A.. The 510(k) number is K961759.

When did CEMENT AND BONE REMOVAL KIT receive FDA 510(k) clearance?

CEMENT AND BONE REMOVAL KIT received FDA 510(k) clearance on 1996-06-13, under 510(k) number K961759.

Who is the listed applicant for CEMENT AND BONE REMOVAL KIT?

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

What is the FDA product code for CEMENT AND BONE REMOVAL KIT?

The FDA product code for CEMENT AND BONE REMOVAL KIT is HWE.

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Related Devices (Code: HWE)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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