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FDA 510(k)

THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10

K-Number: K050101 · 2005-04-15

ApplicantZimmer Trabecular
Decision Date2005-04-15
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10 is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Trabecular. It received FDA 510(k) clearance on 2005-04-15 under 510(k) number K050101. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10?

THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10 is a medical device that received FDA 510(k) clearance on 2005-04-15. The listed applicant is Zimmer Trabecular. The 510(k) number is K050101.

When did THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10 receive FDA 510(k) clearance?

THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10 received FDA 510(k) clearance on 2005-04-15, under 510(k) number K050101.

Who is the listed applicant for THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10?

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

What is the FDA product code for THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10?

The FDA product code for THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10 is HRS.

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Other records listing Zimmer Trabecular 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.

K061155VISTA P VERTEBRAL BODY REPLACEMENT SYSTEMK061067TRABECULAR METAL ACETABULAR AUGMENTSK053340TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTSK052950THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT SYSTEMK051756MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZK050766EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM

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Related Devices (Code: HRS)

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.

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

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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