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FDA 510(k)

TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA

K-Number: K010529 · 2001-04-27

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2001-04-27
Product CodeJDI
Advisory CommitteeOR
DecisionUnknown

Device Summary

TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2001-04-27 under 510(k) number K010529. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA?

TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA is a medical device that received FDA 510(k) clearance on 2001-04-27. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K010529.

When did TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA receive FDA 510(k) clearance?

TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA received FDA 510(k) clearance on 2001-04-27, under 510(k) number K010529.

Who is the listed applicant for TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA?

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

What is the FDA product code for TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA?

The FDA product code for TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA is JDI.

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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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