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FDA 510(k)

TOWNLEY ALL POLY ACETABULAR CUP

K-Number: K952731 · 1995-12-28

ApplicantBiologically Oriented Prostheses
Decision Date1995-12-28
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TOWNLEY ALL POLY ACETABULAR CUP is the device name listed in this FDA 510(k) record. The listed applicant is Biologically Oriented Prostheses. It received FDA 510(k) clearance on 1995-12-28 under 510(k) number K952731. 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 TOWNLEY ALL POLY ACETABULAR CUP?

TOWNLEY ALL POLY ACETABULAR CUP is a medical device that received FDA 510(k) clearance on 1995-12-28. The listed applicant is Biologically Oriented Prostheses. The 510(k) number is K952731.

When did TOWNLEY ALL POLY ACETABULAR CUP receive FDA 510(k) clearance?

TOWNLEY ALL POLY ACETABULAR CUP received FDA 510(k) clearance on 1995-12-28, under 510(k) number K952731.

Who is the listed applicant for TOWNLEY ALL POLY ACETABULAR CUP?

The FDA 510(k) record lists Biologically Oriented Prostheses as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOWNLEY ALL POLY ACETABULAR CUP?

The FDA product code for TOWNLEY ALL POLY ACETABULAR CUP is JDI.

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Other records listing Biologically Oriented Prostheses 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.

K002325WUJIN #3 TIBIAL NAILK992144BIOPRO RIMMED ACETABULAR COMPOMENTK964472RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENTK962769HORIZON HIP SYSTEMK955916TOWNLEY TOTAL ELBOW SYSTEMK954768BIOPRO HEMI-ENDO MODULAR CERAMIC 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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