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FDA 510(k)

SYNERGY 4.0 MM, 4.5 MM VLS SCREWS

K-Number: K011437 · 2001-06-06

ApplicantInterpore Cross Intl.
Decision Date2001-06-06
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNERGY 4.0 MM, 4.5 MM VLS SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Interpore Cross Intl.. It received FDA 510(k) clearance on 2001-06-06 under 510(k) number K011437. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNERGY 4.0 MM, 4.5 MM VLS SCREWS?

SYNERGY 4.0 MM, 4.5 MM VLS SCREWS is a medical device that received FDA 510(k) clearance on 2001-06-06. The listed applicant is Interpore Cross Intl.. The 510(k) number is K011437.

When did SYNERGY 4.0 MM, 4.5 MM VLS SCREWS receive FDA 510(k) clearance?

SYNERGY 4.0 MM, 4.5 MM VLS SCREWS received FDA 510(k) clearance on 2001-06-06, under 510(k) number K011437.

Who is the listed applicant for SYNERGY 4.0 MM, 4.5 MM VLS SCREWS?

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

What is the FDA product code for SYNERGY 4.0 MM, 4.5 MM VLS SCREWS?

The FDA product code for SYNERGY 4.0 MM, 4.5 MM VLS SCREWS is MNI.

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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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