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FDA 510(k)

BIOPRO DRG CUSTOM HIP REPLACEMENT SYSTEM

K-Number: K920145 · 1992-10-15

ApplicantBiopro, Inc.
Decision Date1992-10-15
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOPRO DRG CUSTOM HIP REPLACEMENT 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 1992-10-15 under 510(k) number K920145. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPRO DRG CUSTOM HIP REPLACEMENT SYSTEM?

BIOPRO DRG CUSTOM HIP REPLACEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1992-10-15. The listed applicant is Biopro, Inc.. The 510(k) number is K920145.

When did BIOPRO DRG CUSTOM HIP REPLACEMENT SYSTEM receive FDA 510(k) clearance?

BIOPRO DRG CUSTOM HIP REPLACEMENT SYSTEM received FDA 510(k) clearance on 1992-10-15, under 510(k) number K920145.

Who is the listed applicant for BIOPRO DRG CUSTOM HIP REPLACEMENT 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 DRG CUSTOM HIP REPLACEMENT SYSTEM?

The FDA product code for BIOPRO DRG CUSTOM HIP REPLACEMENT SYSTEM is LZO.

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Other records listing Biopro, Inc. as applicant

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Related Devices (Code: LZO)

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.

K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.K253948Momentum Acetabular Cup SystemUnited Orthopedic CorporationK261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast 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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