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FDA 510(k)

ACRYL-X II SYSTEM

K-Number: K930629 · 1994-01-21

ApplicantSonokinetics, Inc.
Decision Date1994-01-21
Product CodeLZV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACRYL-X II SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sonokinetics, Inc.. It received FDA 510(k) clearance on 1994-01-21 under 510(k) number K930629. The device is classified under product code LZV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACRYL-X II SYSTEM?

ACRYL-X II SYSTEM is a medical device that received FDA 510(k) clearance on 1994-01-21. The listed applicant is Sonokinetics, Inc.. The 510(k) number is K930629.

When did ACRYL-X II SYSTEM receive FDA 510(k) clearance?

ACRYL-X II SYSTEM received FDA 510(k) clearance on 1994-01-21, under 510(k) number K930629.

Who is the listed applicant for ACRYL-X II SYSTEM?

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

What is the FDA product code for ACRYL-X II SYSTEM?

The FDA product code for ACRYL-X II SYSTEM is LZV.

Related Clinical Trials

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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Other records listing Sonokinetics, Inc. 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.

K990572SONOTOMEK911548ACRYL-X SYSTEM TM

Related Devices (Code: LZV)

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.

K021502OSCAR, MODEL OE3000Orthosonics, Ltd.K961101STRYKER CEMENT REMOVAL SYSTEMStryker Corp.K904156ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITSOrigin Medsystems, Inc.K904180PROSTHETIC CEMENT REMOVEROrigin Medsystems, Inc.K891472IMPLANT TECHNOLOGY BONE CEMENT EXTRACTORImplant Technology, Inc.K890285PROSTHETIC CEMENT REMOVERAlbert K. Chin

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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