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FDA 510(k)

DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES

K-Number: K050210 · 2005-07-19

ApplicantBiomet, Inc.
Decision Date2005-07-19
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2005-07-19 under 510(k) number K050210. 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 DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES?

DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES is a medical device that received FDA 510(k) clearance on 2005-07-19. The listed applicant is Biomet, Inc.. The 510(k) number is K050210.

When did DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES receive FDA 510(k) clearance?

DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES received FDA 510(k) clearance on 2005-07-19, under 510(k) number K050210.

Who is the listed applicant for DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES?

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

What is the FDA product code for DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES?

The FDA product code for DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES is JWH.

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Other records listing Biomet, Inc. as applicant

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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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