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FDA 510(k)

MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ

K-Number: K051756 · 2005-07-27

ApplicantZimmer Trabecular
Decision Date2005-07-27
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Trabecular. It received FDA 510(k) clearance on 2005-07-27 under 510(k) number K051756. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ?

MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ is a medical device that received FDA 510(k) clearance on 2005-07-27. The listed applicant is Zimmer Trabecular. The 510(k) number is K051756.

When did MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ receive FDA 510(k) clearance?

MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ received FDA 510(k) clearance on 2005-07-27, under 510(k) number K051756.

Who is the listed applicant for MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ?

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 MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ?

The FDA product code for MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ is JWH.

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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 SYSTEMK050766EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEMK050937TRABECULAR METAL ACETABULAR REVISION SHELLS

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Related Devices (Code: JWH)

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.

K262057GMK ExtensionMedacta International SAK260063GSPE SpacerThe General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

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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