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FDA 510(k)

MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004

K-Number: K050699 · 2005-04-15

ApplicantAmedica Corp.
Decision Date2005-04-15
Product CodeJDK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004 is the device name listed in this FDA 510(k) record. The listed applicant is Amedica Corp.. It received FDA 510(k) clearance on 2005-04-15 under 510(k) number K050699. The device is classified under product code JDK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004?

MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004 is a medical device that received FDA 510(k) clearance on 2005-04-15. The listed applicant is Amedica Corp.. The 510(k) number is K050699.

When did MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004 receive FDA 510(k) clearance?

MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004 received FDA 510(k) clearance on 2005-04-15, under 510(k) number K050699.

Who is the listed applicant for MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004?

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

What is the FDA product code for MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004?

The FDA product code for MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004 is JDK.

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Related Devices (Code: JDK)

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.

K210062Mectaplug PE IIMedacta International S.A.K061465KMI CEMENT RESTRICTOR IMPLANTKinetikos Medical, Inc.K061698MODIFICATION TO LIFE SPINE CEMENT RESTRICTORLife SpineK060247LIFE SPINE CEMENT RESTRICTORLife SpineK060132SPINAL USA CEMENT RESTRICTOR SYSTEMSpinal USAK051371INTERBODY INNOVATIONS CEMENT RESTRICTORInterbody Innovations, Llp

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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