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FDA 510(k)

AESCULAP SIBD XP SPINAL SYSTEM

K-Number: K111122 · 2011-08-04

ApplicantAesculap Implant Systems, Inc.
Decision Date2011-08-04
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AESCULAP SIBD XP SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap Implant Systems, Inc.. It received FDA 510(k) clearance on 2011-08-04 under 510(k) number K111122. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AESCULAP SIBD XP SPINAL SYSTEM?

AESCULAP SIBD XP SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2011-08-04. The listed applicant is Aesculap Implant Systems, Inc.. The 510(k) number is K111122.

When did AESCULAP SIBD XP SPINAL SYSTEM receive FDA 510(k) clearance?

AESCULAP SIBD XP SPINAL SYSTEM received FDA 510(k) clearance on 2011-08-04, under 510(k) number K111122.

Who is the listed applicant for AESCULAP SIBD XP SPINAL SYSTEM?

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

What is the FDA product code for AESCULAP SIBD XP SPINAL SYSTEM?

The FDA product code for AESCULAP SIBD XP SPINAL SYSTEM is OVD.

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Related Devices (Code: OVD)

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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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