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FDA 510(k)

DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS

K-Number: K090998 · 2009-06-12

ApplicantDePuy Orthopaedics, Inc.
Decision Date2009-06-12
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS 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 2009-06-12 under 510(k) number K090998. 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 DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS?

DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS is a medical device that received FDA 510(k) clearance on 2009-06-12. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K090998.

When did DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS receive FDA 510(k) clearance?

DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS received FDA 510(k) clearance on 2009-06-12, under 510(k) number K090998.

Who is the listed applicant for DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS?

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 DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS?

The FDA product code for DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS is JDI.

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Other records listing DePuy Orthopaedics, Inc. as applicant

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Related Devices (Code: JDI)

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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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