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FDA 510(k)

HALL MODULAR ACETABULAR REAMER SYSTEM

K-Number: K960852 · 1996-03-20

ApplicantLinvatec Corp.
Decision Date1996-03-20
Product CodeHWE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HALL MODULAR ACETABULAR REAMER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Corp.. It received FDA 510(k) clearance on 1996-03-20 under 510(k) number K960852. 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 HALL MODULAR ACETABULAR REAMER SYSTEM?

HALL MODULAR ACETABULAR REAMER SYSTEM is a medical device that received FDA 510(k) clearance on 1996-03-20. The listed applicant is Linvatec Corp.. The 510(k) number is K960852.

When did HALL MODULAR ACETABULAR REAMER SYSTEM receive FDA 510(k) clearance?

HALL MODULAR ACETABULAR REAMER SYSTEM received FDA 510(k) clearance on 1996-03-20, under 510(k) number K960852.

Who is the listed applicant for HALL MODULAR ACETABULAR REAMER SYSTEM?

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

What is the FDA product code for HALL MODULAR ACETABULAR REAMER SYSTEM?

The FDA product code for HALL MODULAR ACETABULAR REAMER SYSTEM 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

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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