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FDA 510(k)

PGR HIP STEM (ENDOPROSTHESIS) FOR LARGE BONE RESEC

K-Number: K896851 · 1991-01-01

ApplicantLima Intl. Corp.
Decision Date1991-01-01
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PGR HIP STEM (ENDOPROSTHESIS) FOR LARGE BONE RESEC is the device name listed in this FDA 510(k) record. The listed applicant is Lima Intl. Corp.. It received FDA 510(k) clearance on 1991-01-01 under 510(k) number K896851. 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 PGR HIP STEM (ENDOPROSTHESIS) FOR LARGE BONE RESEC?

PGR HIP STEM (ENDOPROSTHESIS) FOR LARGE BONE RESEC is a medical device that received FDA 510(k) clearance on 1991-01-01. The listed applicant is Lima Intl. Corp.. The 510(k) number is K896851.

When did PGR HIP STEM (ENDOPROSTHESIS) FOR LARGE BONE RESEC receive FDA 510(k) clearance?

PGR HIP STEM (ENDOPROSTHESIS) FOR LARGE BONE RESEC received FDA 510(k) clearance on 1991-01-01, under 510(k) number K896851.

Who is the listed applicant for PGR HIP STEM (ENDOPROSTHESIS) FOR LARGE BONE RESEC?

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

What is the FDA product code for PGR HIP STEM (ENDOPROSTHESIS) FOR LARGE BONE RESEC?

The FDA product code for PGR HIP STEM (ENDOPROSTHESIS) FOR LARGE BONE RESEC is JDI.

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Other records listing Lima Intl. Corp. 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.

K922613CL HIP STEM H/A COATEDK910836LIMA COLLARED CL STEMK900051MOORE TYPE ENDO PROSTHESISK902621SL-SELF LOCKING TOTAL HIP-FEMORAL COMPONENTK896850LIMA CERAMIC FEMORAL HEAD BIOLOX BY FELDMUEHLEK900257MULLER TYPE ACETABULAR CUP

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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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