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FDA 510(k)

AVALON CUP SYSTEM

K-Number: K011887 · 2001-12-27

ApplicantOrthopedic Source, Inc.
Decision Date2001-12-27
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AVALON CUP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Source, Inc.. It received FDA 510(k) clearance on 2001-12-27 under 510(k) number K011887. 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 AVALON CUP SYSTEM?

AVALON CUP SYSTEM is a medical device that received FDA 510(k) clearance on 2001-12-27. The listed applicant is Orthopedic Source, Inc.. The 510(k) number is K011887.

When did AVALON CUP SYSTEM receive FDA 510(k) clearance?

AVALON CUP SYSTEM received FDA 510(k) clearance on 2001-12-27, under 510(k) number K011887.

Who is the listed applicant for AVALON CUP SYSTEM?

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

What is the FDA product code for AVALON CUP SYSTEM?

The FDA product code for AVALON CUP SYSTEM is JDI.

Related Clinical Trials

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.

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Other records listing Orthopedic Source, 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.

K061124ORTHOPEDIC SOURCE PRESS-FIT HIPK022711MODIFICATION TO AVALON CUP SYSTEM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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