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FDA 510(k)

MODIFICATION TO DEPUY C-STEM SYSTEM

K-Number: K013350 · 2001-11-07

ApplicantDePuy Orthopaedics, Inc.
Decision Date2001-11-07
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO DEPUY C-STEM SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2001-11-07 under 510(k) number K013350. 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 MODIFICATION TO DEPUY C-STEM SYSTEM?

MODIFICATION TO DEPUY C-STEM SYSTEM is a medical device that received FDA 510(k) clearance on 2001-11-07. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K013350.

When did MODIFICATION TO DEPUY C-STEM SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO DEPUY C-STEM SYSTEM received FDA 510(k) clearance on 2001-11-07, under 510(k) number K013350.

Who is the listed applicant for MODIFICATION TO DEPUY C-STEM SYSTEM?

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

What is the FDA product code for MODIFICATION TO DEPUY C-STEM SYSTEM?

The FDA product code for MODIFICATION TO DEPUY C-STEM SYSTEM is JDI.

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Other records listing DePuy Orthopaedics, Inc. as applicant

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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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