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FDA 510(k)

BIOPRO METAL BACKED CEMENTED ACETABULAR CUP

K-Number: K910352 · 1991-06-13

ApplicantBiopro, Inc.
Decision Date1991-06-13
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOPRO METAL BACKED CEMENTED ACETABULAR CUP is the device name listed in this FDA 510(k) record. The listed applicant is Biopro, Inc.. It received FDA 510(k) clearance on 1991-06-13 under 510(k) number K910352. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPRO METAL BACKED CEMENTED ACETABULAR CUP?

BIOPRO METAL BACKED CEMENTED ACETABULAR CUP is a medical device that received FDA 510(k) clearance on 1991-06-13. The listed applicant is Biopro, Inc.. The 510(k) number is K910352.

When did BIOPRO METAL BACKED CEMENTED ACETABULAR CUP receive FDA 510(k) clearance?

BIOPRO METAL BACKED CEMENTED ACETABULAR CUP received FDA 510(k) clearance on 1991-06-13, under 510(k) number K910352.

Who is the listed applicant for BIOPRO METAL BACKED CEMENTED ACETABULAR CUP?

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 METAL BACKED CEMENTED ACETABULAR CUP?

The FDA product code for BIOPRO METAL BACKED CEMENTED ACETABULAR CUP is JDI.

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Other records listing Biopro, Inc. as applicant

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K163627Shotel Ankle Arthrodesis Nail SystemK162674BioPro Foot Plating SystemsK132510BIOPRO - INFINITY PLATE ANCHOR SYSTEMK130298BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEMK121973BIOPRO HEMI-EDGE TOE SYSTEMK100761BIOPRO POLAR HEAD

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Related Devices (Code: JDI)

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.

K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer BiometK240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics

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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