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FDA 510(k)

CHESAPEAKE SPINAL SYSTEM

K-Number: K092211 · 2010-03-05

ApplicantK2m, Inc.
Decision Date2010-03-05
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CHESAPEAKE SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2010-03-05 under 510(k) number K092211. 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 CHESAPEAKE SPINAL SYSTEM?

CHESAPEAKE SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2010-03-05. The listed applicant is K2m, Inc.. The 510(k) number is K092211.

When did CHESAPEAKE SPINAL SYSTEM receive FDA 510(k) clearance?

CHESAPEAKE SPINAL SYSTEM received FDA 510(k) clearance on 2010-03-05, under 510(k) number K092211.

Who is the listed applicant for CHESAPEAKE SPINAL SYSTEM?

The FDA 510(k) record lists K2m, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHESAPEAKE SPINAL SYSTEM?

The FDA product code for CHESAPEAKE 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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