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FDA 510(k)

PE-PLUS ACETABULAR CUP

K-Number: K992153 · 1999-09-23

ApplicantPlus Orthopedics
Decision Date1999-09-23
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PE-PLUS ACETABULAR CUP is the device name listed in this FDA 510(k) record. The listed applicant is Plus Orthopedics. It received FDA 510(k) clearance on 1999-09-23 under 510(k) number K992153. 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 PE-PLUS ACETABULAR CUP?

PE-PLUS ACETABULAR CUP is a medical device that received FDA 510(k) clearance on 1999-09-23. The listed applicant is Plus Orthopedics. The 510(k) number is K992153.

When did PE-PLUS ACETABULAR CUP receive FDA 510(k) clearance?

PE-PLUS ACETABULAR CUP received FDA 510(k) clearance on 1999-09-23, under 510(k) number K992153.

Who is the listed applicant for PE-PLUS ACETABULAR CUP?

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

What is the FDA product code for PE-PLUS ACETABULAR CUP?

The FDA product code for PE-PLUS ACETABULAR CUP is JDI.

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Other records listing Plus Orthopedics 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.

K032126PROMOS SHOULDERK033763MODIFICATION TO SLIM GLIDING NAIL SYSTEMK032709MODULAR PLUS HIP STEMK032548IP-XS COMPRESSION NAIL SYSTEMK032215VKS/TC-PLUS REVISION KNEEK032052UC-PLUS SOLUTION UNICONDYLAR KNEE

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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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