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FDA 510(k)

BIOPRO PC FEMORAL HIP COMPONENT

K-Number: K882146 · 1988-08-29

ApplicantBiopro, Inc.
Decision Date1988-08-29
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

BIOPRO PC FEMORAL HIP COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Biopro, Inc.. It received FDA 510(k) clearance on 1988-08-29 under 510(k) number K882146. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the BIOPRO PC FEMORAL HIP COMPONENT?

BIOPRO PC FEMORAL HIP COMPONENT is a medical device that received FDA 510(k) clearance on 1988-08-29. The listed applicant is Biopro, Inc.. The 510(k) number is K882146.

When did BIOPRO PC FEMORAL HIP COMPONENT receive FDA 510(k) clearance?

BIOPRO PC FEMORAL HIP COMPONENT received FDA 510(k) clearance on 1988-08-29, under 510(k) number K882146.

Who is the listed applicant for BIOPRO PC FEMORAL HIP COMPONENT?

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 PC FEMORAL HIP COMPONENT?

The FDA product code for BIOPRO PC FEMORAL HIP COMPONENT is JDI.

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Other records listing Biopro, 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.

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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