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FDA 510(k)

DEPUY PULSE ANTERIOR CERVICAL IN-LINE PLATE SYSTEM

K-Number: K123167 · 2012-12-28

ApplicantMedos International SARL
Decision Date2012-12-28
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEPUY PULSE ANTERIOR CERVICAL IN-LINE PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2012-12-28 under 510(k) number K123167. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEPUY PULSE ANTERIOR CERVICAL IN-LINE PLATE SYSTEM?

DEPUY PULSE ANTERIOR CERVICAL IN-LINE PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2012-12-28. The listed applicant is Medos International SARL. The 510(k) number is K123167.

When did DEPUY PULSE ANTERIOR CERVICAL IN-LINE PLATE SYSTEM receive FDA 510(k) clearance?

DEPUY PULSE ANTERIOR CERVICAL IN-LINE PLATE SYSTEM received FDA 510(k) clearance on 2012-12-28, under 510(k) number K123167.

Who is the listed applicant for DEPUY PULSE ANTERIOR CERVICAL IN-LINE PLATE SYSTEM?

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

What is the FDA product code for DEPUY PULSE ANTERIOR CERVICAL IN-LINE PLATE SYSTEM?

The FDA product code for DEPUY PULSE ANTERIOR CERVICAL IN-LINE PLATE SYSTEM is KWQ.

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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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