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FDA 510(k)

BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEM

K-Number: K895886 · 1989-12-01

ApplicantBiopro, Inc.
Decision Date1989-12-01
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biopro, Inc.. It received FDA 510(k) clearance on 1989-12-01 under 510(k) number K895886. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEM?

BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEM is a medical device that received FDA 510(k) clearance on 1989-12-01. The listed applicant is Biopro, Inc.. The 510(k) number is K895886.

When did BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEM receive FDA 510(k) clearance?

BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEM received FDA 510(k) clearance on 1989-12-01, under 510(k) number K895886.

Who is the listed applicant for BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEM?

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

What is the FDA product code for BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEM?

The FDA product code for BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEM is KWL.

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Other records listing Biopro, Inc. as applicant

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Related Devices (Code: KWL)

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.

K262290REMEDY POLY+PLUS SNAP FIT Acetabular CupOsteoremedies, LLCK260536Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementDepuy Ireland UCK253675OsteoRemedies Hip Spacer SystemOsteoremedies, LLCK252326InterSpace GV Hip SpacerTecres S.P.A.K242865Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder SpacerBiocomposites, Ltd.K234028COPAL® exchange G hip spacer; COPAL® G+VHeraeus Medical GmbH

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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