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FDA 510(k)

ELIBRA DYNAMIC KNEE BALANCER

K-Number: K070108 · 2007-04-04

ApplicantSynvasive Technology, Inc.
Decision Date2007-04-04
Product CodeONN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ELIBRA DYNAMIC KNEE BALANCER is the device name listed in this FDA 510(k) record. The listed applicant is Synvasive Technology, Inc.. It received FDA 510(k) clearance on 2007-04-04 under 510(k) number K070108. The device is classified under product code ONN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELIBRA DYNAMIC KNEE BALANCER?

ELIBRA DYNAMIC KNEE BALANCER is a medical device that received FDA 510(k) clearance on 2007-04-04. The listed applicant is Synvasive Technology, Inc.. The 510(k) number is K070108.

When did ELIBRA DYNAMIC KNEE BALANCER receive FDA 510(k) clearance?

ELIBRA DYNAMIC KNEE BALANCER received FDA 510(k) clearance on 2007-04-04, under 510(k) number K070108.

Who is the listed applicant for ELIBRA DYNAMIC KNEE BALANCER?

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

What is the FDA product code for ELIBRA DYNAMIC KNEE BALANCER?

The FDA product code for ELIBRA DYNAMIC KNEE BALANCER is ONN.

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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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