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FDA 510(k)

AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM

K-Number: K100802 · 2010-07-20

ApplicantAesculap Implant Systems, Inc.
Decision Date2010-07-20
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AESCULAP IMPLANT SYSTEMS SIBD 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 2010-07-20 under 510(k) number K100802. 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 IMPLANT SYSTEMS SIBD SPINAL SYSTEM?

AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2010-07-20. The listed applicant is Aesculap Implant Systems, Inc.. The 510(k) number is K100802.

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

AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM received FDA 510(k) clearance on 2010-07-20, under 510(k) number K100802.

Who is the listed applicant for AESCULAP IMPLANT SYSTEMS SIBD 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 IMPLANT SYSTEMS SIBD SPINAL SYSTEM?

The FDA product code for AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM is 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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