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FDA 510(k)

MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM

K-Number: K011556 · 2001-11-16

ApplicantAesculap, Inc.
Decision Date2001-11-16
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2001-11-16 under 510(k) number K011556. 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 MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM?

MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM is a medical device that received FDA 510(k) clearance on 2001-11-16. The listed applicant is Aesculap, Inc.. The 510(k) number is K011556.

When did MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM receive FDA 510(k) clearance?

MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM received FDA 510(k) clearance on 2001-11-16, under 510(k) number K011556.

Who is the listed applicant for MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM?

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

What is the FDA product code for MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM?

The FDA product code for MACS HMA ANTERIOR SPINAL STABILIZATION 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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