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FDA 510(k)

VERSALINK TITANIUM ROD-TO-ROD COUPLERS

K-Number: K003384 · 2000-11-24

ApplicantOsteotech, Inc.
Decision Date2000-11-24
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VERSALINK TITANIUM ROD-TO-ROD COUPLERS is the device name listed in this FDA 510(k) record. The listed applicant is Osteotech, Inc.. It received FDA 510(k) clearance on 2000-11-24 under 510(k) number K003384. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERSALINK TITANIUM ROD-TO-ROD COUPLERS?

VERSALINK TITANIUM ROD-TO-ROD COUPLERS is a medical device that received FDA 510(k) clearance on 2000-11-24. The listed applicant is Osteotech, Inc.. The 510(k) number is K003384.

When did VERSALINK TITANIUM ROD-TO-ROD COUPLERS receive FDA 510(k) clearance?

VERSALINK TITANIUM ROD-TO-ROD COUPLERS received FDA 510(k) clearance on 2000-11-24, under 510(k) number K003384.

Who is the listed applicant for VERSALINK TITANIUM ROD-TO-ROD COUPLERS?

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

What is the FDA product code for VERSALINK TITANIUM ROD-TO-ROD COUPLERS?

The FDA product code for VERSALINK TITANIUM ROD-TO-ROD COUPLERS is MNH. This falls under the ENT category.

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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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