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FDA 510(k)

ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS

K-Number: K904156 · 1990-11-27

ApplicantOrigin Medsystems, Inc.
Decision Date1990-11-27
Product CodeLZV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS is the device name listed in this FDA 510(k) record. The listed applicant is Origin Medsystems, Inc.. It received FDA 510(k) clearance on 1990-11-27 under 510(k) number K904156. 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 ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS?

ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS is a medical device that received FDA 510(k) clearance on 1990-11-27. The listed applicant is Origin Medsystems, Inc.. The 510(k) number is K904156.

When did ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS receive FDA 510(k) clearance?

ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS received FDA 510(k) clearance on 1990-11-27, under 510(k) number K904156.

Who is the listed applicant for ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS?

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

What is the FDA product code for ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS?

The FDA product code for ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS is LZV.

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Other records listing Origin Medsystems, 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.

K992353BLUNT TIP TROCAR PORTK981700VASOVIEW DISSECTION/VESSEL HARVESTING SYSTEMK972685ORIGIN LIGATOR DEVICEK970611ORIGIN CARDIAC STABLIZER OCCLUDERK965121CANNULAK964171VASOVIEW BALLOON DISSECTION SYSTEM

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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.K930629ACRYL-X II SYSTEMSonokinetics, 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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