FDA 510(k)

4CIS PEEK, PLIF AND TLIF CAGE SYSTEM

K-Number: K092162 · 2010-01-06

Decision Date2010-01-06

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

4CIS PEEK, PLIF AND TLIF CAGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Solco Biomedical Co., Ltd.. It received FDA 510(k) clearance on 2010-01-06 under 510(k) number K092162. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 4CIS PEEK, PLIF AND TLIF CAGE SYSTEM?

4CIS PEEK, PLIF AND TLIF CAGE SYSTEM is a medical device that received FDA 510(k) clearance on 2010-01-06. The listed applicant is Solco Biomedical Co., Ltd.. The 510(k) number is K092162.

When did 4CIS PEEK, PLIF AND TLIF CAGE SYSTEM receive FDA 510(k) clearance?

4CIS PEEK, PLIF AND TLIF CAGE SYSTEM received FDA 510(k) clearance on 2010-01-06, under 510(k) number K092162.

Who is the listed applicant for 4CIS PEEK, PLIF AND TLIF CAGE SYSTEM?

The FDA 510(k) record lists Solco Biomedical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 4CIS PEEK, PLIF AND TLIF CAGE SYSTEM?

The FDA product code for 4CIS PEEK, PLIF AND TLIF CAGE SYSTEM is MAX.

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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.