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FDA 510(k)

INTEGRITY TOTAL HIP SYSTEM, NON-POROUS

K-Number: K941486 · 1994-09-20

ApplicantKirschner Medical Corp.
Decision Date1994-09-20
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTEGRITY TOTAL HIP SYSTEM, NON-POROUS is the device name listed in this FDA 510(k) record. The listed applicant is Kirschner Medical Corp.. It received FDA 510(k) clearance on 1994-09-20 under 510(k) number K941486. 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 INTEGRITY TOTAL HIP SYSTEM, NON-POROUS?

INTEGRITY TOTAL HIP SYSTEM, NON-POROUS is a medical device that received FDA 510(k) clearance on 1994-09-20. The listed applicant is Kirschner Medical Corp.. The 510(k) number is K941486.

When did INTEGRITY TOTAL HIP SYSTEM, NON-POROUS receive FDA 510(k) clearance?

INTEGRITY TOTAL HIP SYSTEM, NON-POROUS received FDA 510(k) clearance on 1994-09-20, under 510(k) number K941486.

Who is the listed applicant for INTEGRITY TOTAL HIP SYSTEM, NON-POROUS?

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

What is the FDA product code for INTEGRITY TOTAL HIP SYSTEM, NON-POROUS?

The FDA product code for INTEGRITY TOTAL HIP SYSTEM, NON-POROUS is JDI.

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Other records listing Kirschner Medical 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.

K940537KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEMK936274KIRSCHNER PERFORMANCE POSTERIOR STABILIZED TOTAL KNEE SYSTEMK942891SUMMIT TOTAL HIP SYSTEMK933843LINE EXTENSION FOR KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS COATEDK935951KIRSCHNER C-2 OSTEOCAP TOTAL HIP SYSTEMK935206KIRSCHNER INTEGRITY ACETABULAR CUP MODIFICATION

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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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